Theradome™ Laser Helmet

Jacob · Post by **Jacob** » Mon Oct 07, 2013 8:18 pm

The First and Only FDA OTC Cleared Clinical Strength Laser Hair Therapy for Home Use

I've invited them to tell us more about their helmet. Who knows if they'll show up..but it'd be nice to get this section of the forum going a bit.
I'd like to know what they mean with that above quote as well. I noticed the "Igrow" one claims it's FDA cleared. But then I guess they wouldn't consider it "clinical strength"- doesn't look like it has as much coverage.

For anyone wondering..I've never used such a device myself. The Laser Comb was tempting way back in the beginning, but besides the $, I just knew I wouldn't stick with something you have to hold in your hand and move along the scalp yourself for however many minutes you're supposed to. Next the do-it-yourself helmet crazy happened..which I didn't care to do myself. Then certain folks started making them and selling them- won't get into that here. Then many other options became available(I think there's a start of a list here, somewhere)..including that expensive LaserCap.

Price isn't TOO bad on this one. I noticed it was quite a bit cheaper when they were seeking funds or whatever to get their company/product going. But it's still one of the cheaper helmets I've seen around.

Any known posters try this thing out? It *looks* comfy..seems like a good product...would like to learn more.

Theradome · Post by **Theradome** » Thu Oct 10, 2013 4:48 pm

Hi Jacob,

Thank you for starting this thread for us, we'd be more than happy to answer any questions regarding our Theradome Laser Helmet.

To clarify-- since March of 2012 we are the first and only FDA OTC (over the counter) cleared clinical strength laser hair therapy device for women. Other products are only cleared for men, and fortunately we will also be receiving our FDA clearance for men by December 2013.

Another thing to note about our helmet is that we use ZERO LED lights, (LED lights have no peer reviewed research to prove they improve hair growth). Instead we have 80 fine-tuned lasers which cover an area of 582 square centimeters (versus the competing 300 square centimeters, ours is about twice the coverage). This number of square centimeters is enough to cover 100% of areas affected by male and female pattern baldness.

As far as price, we offer the best value. For 80 lasers at a price of $695 you are buying each laser for $8.68 (695/80 =$8.68) Compare this to a device with 21 lasers where you are buying each laser for $33.09. Not to mention you don't need a prescription to use our device since it has over-the-counter clearance by the FDA.

100% of subjects who have used the Theradome laser helmet after 18 treatments (20 minutes a treatment) reported that it improves hair shaft quality, thickness and improved their hair manageability. The Theradome laser helmet is not only for hair loss, is it used by many for volumizing and improving the quality of one’s hair which lasts several months.

We'd love to answer more questions about our device.

Thanks!
Jenae Frick
Theradome Team

Jacob · Post by **Jacob** » Fri Oct 11, 2013 12:19 pm

Hello and thanks for stopping in

Just a couple of quick ?'s before I take off for the weekend. I see on the website the price is actually $495 at the moment...was that a typo or was that supposed to be off the site by now? Also, are there any recommendations on what to use or not to use prior to or after laser'n?

Theradome · Post by **Theradome** » Sat Oct 12, 2013 4:58 pm

Hi Jacob,

Great question. First off, since we are in the process of manufacturing our product and will not begin shipping until November, we are currently offering our laser helmet at a discounted price of $495 until tomorrow Sunday Oct.13th, 2013. After that the price will rise to $595 until we finally start to ship in November. That is the reason you see a lower price on our website right now, our customers are receiving a discount since they have to wait longer. After we begin shipping it will cost $695 as the regular retail price.

As for recommendations for what to use before laser treatments -- we recommend you prep the scalp by using three different shampoos, such as Head and Shoulders and T-GEL / T-SAL and leave them on your scalp for at least 5 minutes each and rinse and apply the next one. If you can find Nizoral, you can use this as well, but you can only use this 2 times a week at the most, since it is a bit strong. You can use any conditioner. Using these shampoos will help bring the scalp to a healthier state and provide an optimal condition for laser hair treatments. If you're already using these shampoos, you can continue using them through your Theradome treatments and you will see the difference the Theradome makes.

Jacob · Post by **Jacob** » Tue Oct 15, 2013 7:27 pm

Yeah unfortunately those are the kinds of shampoo I don't care to use, but since my scalp seems to be plenty healthy with what I'm using, I guess it wouldn't make too much of a difference if I ever decided to start laser'n. I know scalp "peels" and exfoliating have been discussed in the past as well for potentially helping.

I was going to ask if it's possible to use or make a battery pack for it..but after checking the site out a bit more I now see it's already cordless- rechargeable even. That's a big plus

Is there a reason why you stopped at 80 lasers(besides the cost)? Some make and sell(so they're basically homemade) helmets with quite a few more lasers, the rationale(I guess) is that more is better.

Thanks again for participating

doke30 · Post by **doke30** » Sat Oct 26, 2013 4:09 am

Hi Jacob and theradome i was considering the igrow laser helmet until i was searching the web and came across theradome and when i saw this thread i thought i would comment i am interested in now trying the helmet but would only try if having the special offer of $300 which was the original starting price i think it went up to $395 then $495 and i do not think if people got this at these prices its fair to have to pay $695 upfront? why does theradome not give us the price of $395 for all hairlossfight forum members? come on theradome give us an incentive? i do not think they will reply whats your say jacob.

doke30 · Post by **doke30** » Sat Oct 26, 2013 4:27 am

i forgot to add if they come back and say that the igrow is $$$$ which i know its in the $600 region but i have been able to shop around and get a quote for $395 so im waiting before i order any helmet as like many on forums not made of money.
Im also not sure whether more lasers are any better than less as igrow helmet has some good reviews even though it combines lasers and leds, but if we can get a discount here i would go for the theradome.

tinytim · Post by **tinytim** » Tue Oct 29, 2013 1:23 am

hi jacob and theradome if you come back here i am interested in a laser helmet and the theradome does fit the bill but i notice that they have succeded in getting big amount of pre order funding without even anyone receiving a helmet as yet? and as they still im not sure sent any product out how do we know we can trust this company with $$$ i do not want to ask this but it is fair as the varying price starting as said in last post to what it states on there web site is not doing the company any favours so come back here and answer these questions as i have mailed them about the comments here and as yet had no reply.

tinytim · Post by **tinytim** » Wed Oct 30, 2013 9:34 am

well jacob and all im very unsure about this company theradome as there not very customer service savvy im wondering what aftersales service they offer due to not responding to questions here and elsewhere which is sad as they want monies upfront.
I was considering ordering this helmet but due to lack of responce i think i will wait and see how long this company lasts.

Theradome · Post by **Theradome** » Wed Oct 30, 2013 12:17 pm

Jacob wrote:Yeah unfortunately those are the kinds of shampoo I don't care to use, but since my scalp seems to be plenty healthy with what I'm using, I guess it wouldn't make too much of a difference if I ever decided to start laser'n. I know scalp "peels" and exfoliating have been discussed in the past as well for potentially helping.

I was going to ask if it's possible to use or make a battery pack for it..but after checking the site out a bit more I now see it's already cordless- rechargeable even. That's a big plus

Is there a reason why you stopped at 80 lasers(besides the cost)? Some make and sell(so they're basically homemade) helmets with quite a few more lasers, the rationale(I guess) is that more is better.

Thanks again for participating

Jacob, we will also be offering our own very specialized shampoo very soon. As far as the battery goes, it comes with a rechargeable battery which lasts about 3 years and can be purchased on our website for $20.

People often think that more lasers is better. However that is not the case at all. In fact, the problem with having hundreds of lasers is that the heat generated from those lasers causes the lasers to actually reduce in functionality and effectiveness. With hundreds of lasers they tend to output around 15-20 degrees of heat which cause a LOT of shedding of hair, due to the over stimulation that occurs from overlapping of lasers and excess heat coming from a small area. Our device has absolutely no shedding effects and our proprietary lasers output a total of 1 degree Celsius over a period of 20 minutes. Theradome actually does the opposite of shedding, we slow or stop hair loss and our results are much more impressive since we manage both heat (low) and still provide maximum dosage for effectiveness due to our proprietary lasers.

Our proprietary lasers are tuned for 678nm, unlike the other lasers which use DVD/CD ROM/laser pointer lasers which are sold by Chinese vendors at 653nm or so. Most of these lasers are used for appliances and gadgets, not hair or dermatology. The issue is that when applying lasers on the human body you have to manage power dosage versus heat and our device is the most powerful AND the most cost effective laser product out there. We cover 100% of the scalp and each of our lasers is much more powerful than the others. For example, you can have 20 lasers at 50mW which gives you 1000mW versus 500 lasers at 2mW, which gives you 1000mW, it really does not matter how many lasers you have, it is the power output of each laser AND how low of heat they output since lasers are very sensitive to heat, and they drop in efficiency with heat.

So to summarize, our helmet is just as effective, if not MORE effective with 80 lasers versus hundreds.

Theradome · Post by **Theradome** » Wed Oct 30, 2013 12:27 pm

doke30 wrote:Hi Jacob and theradome i was considering the igrow laser helmet until i was searching the web and came across theradome and when i saw this thread i thought i would comment i am interested in now trying the helmet but would only try if having the special offer of $300 which was the original starting price i think it went up to $395 then $495 and i do not think if people got this at these prices its fair to have to pay $695 upfront? why does theradome not give us the price of $395 for all hairlossfight forum members? come on theradome give us an incentive? i do not think they will reply whats your say jacob.

You have to understand that our starting price of $395 offered on Indiegogo.com (a crowd funding site) was an exclusive and highly discounted price that was offered to Indiegogo crowd funders who wanted to support our product. After our Indiegogo campaign finished in September, we have been gradually raising the price and we've been very open about letting our customers know when pricing will go up next. The normal retail price for a Theradome will be $895. Right now we offer it for $595 (that's $300 off retail price, but only for a very limited time). We are offering such low pricing because our product is still in production and will not be available until November 2013. Due to the wait that customers need to endure and in exchange for them paying up front to help us manufacture the product, we are offering massive discounts. From the beginning we have been very open about our final pricing and have been telling as many people as possible to order while prices are still low during this pre-order.

Theradome · Post by **Theradome** » Wed Oct 30, 2013 12:31 pm

tinytim wrote:hi jacob and theradome if you come back here i am interested in a laser helmet and the theradome does fit the bill but i notice that they have succeded in getting big amount of pre order funding without even anyone receiving a helmet as yet? and as they still im not sure sent any product out how do we know we can trust this company with $$$ i do not want to ask this but it is fair as the varying price starting as said in last post to what it states on there web site is not doing the company any favours so come back here and answer these questions as i have mailed them about the comments here and as yet had no reply.

Here's what I explained to Doke30, and I think it will help you too:

Our starting price of $395 offered on Indiegogo.com (a crowd funding site) was an exclusive and highly discounted price that was offered to Indiegogo crowd funders who wanted to support our product. After our Indiegogo campaign finished in September, we have been gradually raising the price and we've been very open about letting our customers know when pricing will go up next. The normal retail price for a Theradome is $895. Right now we offer it for $595 (that's $300 off retail price, but only for a very limited time). We are offering such low pricing because our product is still in production and will not be available until November 2013. Due to the wait that customers need to endure for their pre-order and in exchange for them paying up front to help us manufacture the product, we are offering massive discounts. From the beginning we have been very open about our final pricing and have been telling as many people as possible to order while prices are still low during this pre-order.

Hope that info helps.

tinytim · Post by **tinytim** » Thu Oct 31, 2013 4:04 am

many thanks theradome to answering the questions and i notice that the ceo of theradome Tamim Hamid has regrown his hair on the you tube video now has he had a hair transplant because if he has not and the laser helmet alone has regrown his hair it would be a miracle at this time and everyone could give up the lotions and oral drugs and just use the helmet.
By the way jacob have you any comments as you started the thread?

tinytim · Post by **tinytim** » Thu Oct 31, 2013 4:42 am

Well jacob and others i have taken the plunge and pre ordered my theradome helmet due to the company giving me a discount and answering all my emails and the question i got a reply was interesting that the ceo Tamim Hamid has not had any hair surgery and the regrowth he got was from the laser dome. $\:D/$

Jacob · Post by **Jacob** » Sun Dec 08, 2013 6:48 pm

When do you expect to get it?

Edit..I just saw your previous post asking if I had any comments. I think the product looks good..love that the company actually came here to answer questions(at first, at least) and is responding to emails. I'm waiting for their 12 months 0% deal or something

But seriously..this is a bad time for me to get something like this- with Christmas/the Holidays right around the corner etc. I'm looking forward to reading ppl's feedback on it though.

Jacob · Post by **Jacob** » Fri Dec 20, 2013 1:49 pm

Where are Tamin's pictures btw?

Jacob · Post by **Jacob** » Mon Dec 30, 2013 6:24 pm

Received this from someone in another forum..it's a snapshot from the video you see on their website. I hope there are pictures in-between those two...otherwise it's very hard to believe. Having the hair the same length in the "after" as is in the "before" would also help.

Anxious1 · Post by **Anxious1** » Fri Jan 03, 2014 10:01 pm

Jacob · Post by **Jacob** » Sun Feb 09, 2014 12:49 pm

As you can see, more than a month has gone by since the above questions were asked. Others have pointed out their questions were not answered on Facebook, and like me- via email as well. Since they're running away from these questions..there's no need to for them to be able to post here any longer.

About 2 weeks after Anxious1's questions were posted I emailed to let them know in case they hadn't seen the questions. I was told Tamim would be asked and the answers would be posted. That never happened, so I again emailed and still got no answers to the questions, not even via email.

I realize there are excuses being made for them in at least one other forum, but that's all they are..excuses. Those same ppl are going by Tamim's results(see above picture) to decide whether they should use the device daily or not. That before/after proves absolutely nothing, and I have a feeling that's the real reason they quit posting here(doesn't explain the lack of answers elsewhere though). While one could have fun and wonder if the before/after is even of the same person, as I've read others say...anyone with any common sense knows you cannot compare pictures of two drastically different lengths of hair and say- WOW, it works! How exactly did he use that device?! Especially for anyone who's been around these forums for years- you know better.

Good luck to anyone using the device. I'm sure it actually uses real lasers, flat or round(cheap or expensive). It could actually work better than any others. Igrow seems to have gotten better results with their lasers compared to what Theradome is basing theirs around though. Then there's the LaserCap..LazerFish..OMG..etc. There really is no way to say which is the best unless there is a head to head

comparison between them all...on dozens if not hundreds of ppl. I can see why each company would want to say theirs is the best..but if they can't answer questions or it's found they're making stuff up(talking about any of them)....

doke30 · Post by **doke30** » Fri Feb 21, 2014 4:10 am

sorry i have not been here for a while i did cancel my threradome order as it was a lot of money upfront and i was worried i may lose the money so paypal refunded me has anyone received and using the helmet.

Jacob · Post by **Jacob** » Thu Feb 27, 2014 8:34 pm

Not too many are or not too many care to admit they are. Then you have the newbies that show up everywhere- doubt that will continue to happen here...although they're more than welcome to. But so too are any newbies who then want to question things. It's just common sense...non-hypocritical.

I would like to point out one other thing for now. On the website it was(not sure if it's still there) said and also said here:

With hundreds of lasers they tend to output around 15-20 degrees of heat which cause a LOT of shedding of hair, due to the over stimulation that occurs from overlapping of lasers and excess heat coming from a small area. Our device has absolutely no shedding effects and our proprietary lasers output a total of 1 degree Celsius over a period of 20 minutes

Guess what? Theradome users are reporting shedding.

missmyhair14 · Post by **missmyhair14** » Thu Mar 20, 2014 11:33 am

i've been using theradome helmet for almost 2 months and my hair is shedding like crazy. i was not shedding before using helmet. i called theradome and they insist the helmet does not cause shedding. just crazy. it should be disclosed on their website that shedding can occur.

Jacob · Post by **Jacob** » Fri Mar 21, 2014 7:06 am

missmyhair14 wrote:i've been using theradome helmet for almost 2 months and my hair is shedding like crazy. i was not shedding before using helmet. i called theradome and they insist the helmet does not cause shedding. just crazy. it should be disclosed on their website that shedding can occur.

Hey missmyhair14, welcome to HLF and thanks for the feedback.

I think a couple of things could have led to that claim of "no shedding". The few who actually used the thing or at least the specific lasers(in some prototype prior to the Theradome being made) in the beginning didn't notice any shedding and/or never suffered from hair loss to begin with, or it was just another thing that was made up to hype and sell the product(if they're honest they'll take that off the website and stop telling ppl via phone or email that it does not/won't cause shedding). I'm sure you're aware that another selling point was that it's "Made in the USA". Not only is there a sticker in the helmet saying the lasers are made in China, but the CEO/Tamim, when making up an excuse for that sticker being in there, actually admitted the plastic and maybe other things are also from China. I think one poster told me the power source(charger?) was also made in China. Does any or all of it being made in China affect the end results or even the quality? Possibly, but that isn't really the point. They used "Made in the USA" to both raise funds for the project and then to sell it.

Now supposedly they're going to change that sticker to "Made in the USA", but they'd better think twice about doing so if they are not actually made in the USA. Same for the rest of the helmet- I'm sure we'll see a nice big "Made in the USA" on the outside and on the box/package it comes in, etc.

Good luck btw..I don't know if you plan to use it less frequently for awhile or what- to see if the shedding subsides. Some say a shed is "good"..that it means the best is yet to come. I'm not sure I believe that, but hopefully that's the case with you. I know many who shed then claim

I'm getting great regrowth and/or my hair is getting thicker! Yeah..I would hope that shed hair would grow back

Lynnae · Post by **Lynnae** » Tue Apr 01, 2014 4:54 pm

Jacob why didn't you post the pictures you posted here I hope I can post this http://www.hairlosstalk.com/interact/sh ... =theradome

You have become a big name at Hairlosshelp I see HAHA! stevo is even going to see where it is made tomorrow and he brought up you again.
I am trying to decide what laser product to use. Should I go to a salon or buy my own? What is the best?

ĹŶŃŃĂĔ

Jacob · Post by **Jacob** » Tue Apr 01, 2014 8:06 pm

Hello Lynnae..and welcome to HLF.

No problem posting the links. I *requested* those pics..someone who has the helmet posted them. More info has been dug up by myself and others than the 2 in the pm group he keeps yapping about. Now why do I say only 2? While I can see why others would be too embarrassed to "come out of the closet"..just the fact that all this stuff is coming to light outside of such a silly group and the fact that he STILL doesn't have answers to the forum'rs questions(I thought they respond to all questions via email etc??) as well as seeing the other member wondering in the forum about the FDA trial/testing on men(you can see they/many others STILL do not realize Theradome or it's lasers were never used to get their FDA approval- they used a separate clinical device for that..THAT would be something to ask- how that is even possible)...If there was such a pm group they obviously got no information worth sharing. And now we know why they just pretended to have inside information or whatever.

To save time for anyone wondering..here's the pic with the "Made in China" sticker:

I see what you're referring to..what that person said over at HLH: "My meeting is tomorrow with Tamim as he also wanted me to see his manufacturing plant.....you know the one with all the chineeeeeese parts imported from Jacob, Bojac or Nercosis .....in fact maybe I will take some pictures of the shipping containers......chuckle! "

First..it's funny that he announces it on April Fools Day. I am not sure what the "Nercosis" is all about- if that's a name he gave for me or if someone posted there with that name or what. He makes a lot of accusations but hides on that forum because he knows he'd get blown apart anywhere else. Notice also the Theradome works so great for him yet it's the topicals etc that Theradome is coming out with that he's the most excited about. He's been pushing those even before the company knew what they'd contain(they were asked).

On seeing the manufacturing plant. Great. Let's see it. Yet another thing Jacob will then have been able to get out of them. But we already know the helmet parts come from China, so they were already caught in a lie. The only thing I'd be interested in is videos of the lasers/diodes being made- and evidence that the vids are being taken right here in the good 'ole USA- California I think. Let's see an actual address outside the building(anyone remember that peptide company..WMSR or whatever- someone did just that) etc. If that happens, congratulations to any of you that buy the latest helmets. You'll have one with USA made lasers.
Just don't waste our time with still photos of things laying around or ppl pretending to be making something. Or "trust me" B.S.

Hey...you got me started

On the best LLLT device..that's a toss-up. I just have no faith in Theradome with all the shedding(after claiming theirs don't cause a shed) and all their other hype and everything else that's come out. Maybe a new thread on that can be started..or I think there may be an old one to bump up..will do that tomorrow unless someone else beats me to it.

Jacob · Post by **Jacob** » Wed Apr 02, 2014 6:34 am

that post looks longer this morning

Thought I'd post what I got from the MEP-90 folks awhile back:

The MEP-90, as you noticed yourself, has actual first hand clinical data proving its effectiveness. Even though we are aware of Theradome and the fact that the company used the MEP-90 as a predicate device to obtain FDA clearance, we cannot comment on Theradome’s technology or lack thereof.

For anyone doubting that the MEP-90, and not a "Theradome", was used by them to get FDA clearance...

The thread I was thinking of on the various LLLT devices was back in 2008. Others were added here and there since then, but not in that thread. Even by me

Maybe a new thread would be a good idea..could be some others out there we're not aware of.

Lynnae · Post by **Lynnae** » Thu Apr 03, 2014 3:50 pm

I did not mean to get you started!! But you are enjoying it no?? I waited to post until answers were provided from his visit. I am less interested now than before. Many things were not cleared up and he did not post one picture. More excuses than I see answers. I waited to post also to see if he would picture the new sticker inside the helmets that are now Made in the USA. I sent email asking them about and I was sent a picture of the new sticker that said Made in the USA. They did not provide me a picture of the sticker inside the Theradome. They even stopped replying to emails.

ĹŶŃŃĂĔ

Jacob · Post by **Jacob** » Thu Apr 03, 2014 5:31 pm

I'm not going to go too much into it now..maybe I won't, ever..since it's so ridiculous. But ya know...I knew he wouldn't have much when he posted all night instead of providing some answers..and then the same for most of the day. Everything after "At the end of the day!" shows he knows he wasn't able to knock it out of the ballpark. More like yet another strike. But wait- it was limited time! Questions will be forwarded to _____! He did this with another issue/product line(Proctor) as well. In the end he didn't' have the answers. Like you said- excuses. I see ppl are already bringing up the questions again.

Another reason I'll wait is because I cannot believe he doesn't have any pictures. There is no fricken way you hype up such a visit and come back with NOTHING. The only way that happens is if it's so embarrassing. And there is nothing. No mention of seeing the lasers being made- a major one. No pictures of that or all the parts that show they're made in the USA. The processor/circuit board. The facility is "unmatched" but...no pictures. Updating the helmet already..so much for the NASA genius. Nothing on their FDA approval- but we already know. Pictures have to be soon....

To your picture Lynnae....a PICTURE??? Are you part of the pm group or something?

I'd be interested in seeing it. Although if it's not on or in the helmet and they couldn't provide you with a picture of it in a helmet...

I've said this before- anyone ordering it now should receive a helmet with such a sticker, so I can't believe they'd make that up. Now if they're actually made in the USA- there's a way to find out..eventually. But good grief..what a simple request. And after they actually did send you a picture of the sticker.

To your question..I think I'm enjoying it more than some others

Jacob · Post by **Jacob** » Thu Apr 10, 2014 7:12 pm

Posting this for Lynnae..seems we're still having problems with ppl being able to log in and/or retrieve passwords etc. Nothing W

W here except that I don't know why we don't get more information from those supposedly getting or able to get so much information. I could easily have missed it...but I never read anything about the lasers being made in their factory(sounded more like just an assembly set-up)..for sure no pics...etc.

Jacob · Post by **Jacob** » Thu Apr 10, 2014 7:28 pm

I see one of their biggest cheerleaders has almost done a complete 180. Going to bed...maybe I'm already sleeping and dreaming..will find out in the morning...

Edit..nope..wasn't dreaming. Even threats: "Tamin and Janae....are you hearing us?....as it is only going to get worse if you continue to show disrespect!"

...oh Lordy...and here I was so terrible for questioning them after they refused to answer the questions in this thread- asking them via email as well(that's privately

). And then others not having ?'s answered everywhere else. I expect there to be another 180 though. I haven't read that anyone was shown anything actually being made in their assembly factory- I mean molded etc. The lasers being made right there, etc. Right now it's all about being "disrespected"

..so why actually tell everybody everything when there's still a chance you'll once again be able to run your fingers through the CEO's hair.

I'm reading now they've changed the return policy..what one should expect in the amount of time they use the device when the deadline is reached for it to be returned..etc. I really don't understand why and cannot believe a company would even operate like this. Especially given what they did have going for them. Now I'm sure they'll still do fine $-wise..especially going overseas. Unless....

BTW.. this tv station should really be contacted to do another segment on Theradome: http://abclocal.go.com/kgo/story?sectio ... id=9438644 Maybe a more investigative look instead of a free commercial for them.

Lynnae · Post by **Lynnae** » Thu Apr 17, 2014 4:08 pm

I am glad I could get back in here! Thanks for the picture and here is more information than you got on the Mep-90

The FDA has two categories for device clearance or approval. The first one is called the 510K (premarket notification) process and is used for diagnostic instruments such as MRI and ultrasound systems, some basic non-life sustaining therapies (laser hair growth, laser hair removal), etcetera. The second one is the PMA (premarket approval) process for implantable devices delivering a therapy, such as pacemakers. Note that 510K devices are cleared while PMA devices are approved.

In the 510K process you are allowed to use another companies information, even without asking them for permission or informing them that you have done so. Of course, you will have only access to information that is available to the public. A company is allowed to hold back (redact) proprietary information and trade secrets. Take for example the secret formula for coca cola or proprietary information on the MEP-90. In addition, most companies will not submit clinical trial data for their 510K devices since they are not required to do so by the FDA.

Did you see http://www.asrcreviews.org/2014/04/ersp ... in-claims/

ĹŶŃŃĂĔ

Jacob · Post by **Jacob** » Thu Apr 17, 2014 7:02 pm

That actually explains very well how they were able to get FDA approval..err...clearance w/out using their own device or even lasers. I think it's just more evidence how our FDA sucks at "protecting" us etc..but more on that maybe some other time

On that website/page- It'll be interesting to see how they respond to it. I think they could have added more problems/issues but at least someone is reporting on it.

Thanks for all that info- for the "Made in the USA" pic as well

october2000 · Post by **october2000** » Thu May 01, 2014 3:06 pm

The Theradome 510K summary submitted to the FDA, predicates the safety and equivalency of the device off another device, the MEP90. In Section 5 of the 510(k) document Theradome submitted, regarding safety and effectiveness information which led to FDA clearance, is this statement: “The Theradome Laser Helmet LH80 PRO ……….utilizes laser diodes in the helmet to deliver laser stimulation to the ENTIRE SCALP…”).

This statement is allegedly false, misleading and spurious in that the Theradome helmet does NOT “DELIVER LASER STIMULATION TO THE ENTIRE SCALP”. To show this, I suggest that anyone with a Theradome device turn it over and lay a tissue or paper over the laser to see the beam profile. This is the laser beam profile which would be on your scalp. You will clearly see 80 laser SPOTS and then lots of area outside the beam coverage that are NOT receiving any laser energy. In my view there are more areas not receiving any laser energy than areas that are. You will also note that in the most common areas of hair loss that people want to treat, the temporal area (sides of the head) and the vertex (‘bald spot’ on the top of the head in back) has very little laser light coverage and therefore leaves much of the scalp untreated.
Additionally, Theradome calculated the power output of their device, by measuring the energy coming from the laser that lands in a 1 square centimeter. Each laser only covers 1-2 square cm and only these specific sized areas are receiving the full amount of laser energy (HOT SPOTS). Those areas outside of the laser beam coverage are not receiving any laser energy (BLANK SPOTS). Therefore, the Theradome does not “deliver laser stimulation to the entire scalp” as Theradome claims in their 510(k) submission.

Based on this information, I believe that Theradome is allegedly attempting to mislead the FDA and general public, by filing their FDA 510K submission to the FDA with false and misleading information. This to me is a very serious situation, as all FDA submissions need to contain truthful and accurate statements signed by a company officer.

Jacob · Post by **Jacob** » Thu May 01, 2014 6:26 pm

Welcome..and good post. I don't know if they get away with it because they used the MEP-90 info or what. The FDA seems screwed up as well. From what I've read they screwed up on other areas of the design too..including comfort.

I still have yet to see any evidence or rationale as to why their lasers are any better..as keeps being claimed. Also still no pictures, including of the lasers being made..etc. As far as I'm concerned, delays like this just make anything that is provided that much more..unbelievable

The same goes for dodging questions and just saying they've been answered before.

doke30 · Post by **doke30** » Mon May 05, 2014 5:14 am

does the before and after picture look like the same man as the first pic looks like a white guy and the second tamin? also is the company still going after all this hype i myself am very happy i got the igrow and although not a miracle i am glad to keep on using.

Jacob · Post by **Jacob** » Mon May 05, 2014 7:21 pm

All I know is that he just grew his hair out, if that is him in both pictures. Although the (poor)quality and coloring also help. There are some strange ppl in these hair loss forums..that they actually believe the pictures and/or say- well, Tamim used it this frequently, so shouldn't we?

Is the company still going? Is Proctor still going after, from day one(20+years ago), lying about a 3/4 year clinical study and then everything else we've pointed out since?

There are so many other examples one could give. It seems no one goes down unless the FDA takes 'em down(Dr Lee..I think it was the FDA anyway) or there's a lawsuit or something.

doke30 · Post by **doke30** » Tue May 06, 2014 1:10 am

I think that Dr Proctor is still in bussiness but i tried his tiny pot of cream and it was so thick and lumpy i could not spread it well over scalp although he has his followers and the late bryn shelton who had his run ins with you jacob over the years but he still praised proctors product.
I would rather have a natural that worked but i never tried Dr Klines topicals as not only price but he has so many products you do not know what to use in the end ie: 5% minox or his 15% and with spiro of with tretinoin its very confusing.

Jacob · Post by **Jacob** » Thu May 08, 2014 5:31 pm

I'm sure you've seen at HLT the Proctor snake-oil'n thread

It is insane the # of products out there..natural and drugged. New ones coming out every week it seems. Not natural..but have you ever thought about those mega-ingred ones from Spectral/Polaris?

doke30 · Post by **doke30** » Fri May 09, 2014 12:55 am

yes the spectral and polaris labs you problably know are part of the same company and they have so many products it must be a nightmare to many not knowing what to choose.
All of us want a simple to use possable one or two at the most natural products that can stop mpb and regrowth of new hair and at this time im not sure there is anything, and as to the drugs they are no miracle either they do work in some but for me i would like a natural side effect free im going to try the matt miller serum which one of the ingredience is amp adenosine monophosphate from australia have you heard of it jacob?
There is a company in uk selling it now and i have spoken to the guy whos picture is on there site who was bald and he has had some success in turning his grey hair into dark again and getting some regrowth.
Buy the way the matt miller serum is on ebay uk thats where i first heard of it then i tried to find more info before deciding to buy it and found a uk and the autralian web sites.

DRS1964 · Post by **DRS1964** » Thu May 22, 2014 6:11 am

So, I am researching ways to help with my hair loss instead of working and come upon the Theradome Laser Helmet finally landing on this site. I have read through everything and do not see where anyone other than the owner of the Theradome Company has had any results. Before I shell out $895 I was hoping to hear from some real hair loss sufferers who had given the cap a try and had positive results....does it work? My hair loss was initiated via a cross contamination with my husband who is on testosterone replacement therapy. My T levels where that of an average man and I am still shedding hair after 3 months of having a normal female testosterone level. In addition to this happening I have recently become menopausal and feel that my hormone levels are contributing to the continued hair loss. I want to do all I can to try to reinvigorate the hair follicles obviously affected by DHT and try to stave off the general hair thinning of a menopausal woman. Any suggestions are much appreciated....Thanks so much!

eva92watson · Post by **eva92watson** » Mon Jun 16, 2014 1:37 am

I was looking for something informative on Theradome Laser Helmet. Thanks for this post.

suzen · Post by **suzen** » Wed Oct 08, 2014 6:56 pm

Hi all,
In August 2014 I bit the bullet and ordered the Theradome for $945. They took payment and that was the last I heard from them. If I check my order status, it does acknowledge my payment, but only lists my order as unfulfilled. Emails to customer service, sales, and info listing my order number and asking for a sign that I was not left hanging to dry HAVE BEEN UNANSWERED. I post this here to warn others.

I am in Canada, but that doesn't make me a bad person. Does it?

Suzen

Female, "of a certain age" ( 40-50 and holding)
Rogaine, vitamins, herbals. Still losing hair.

Jacob · Post by **Jacob** » Fri Oct 10, 2014 1:01 pm

I'm not surprised...but maybe try posting at Therdome's Facebook page if you Facebook? Not that they give straight and/or honest answers there either..but ya never know.

Welcome to Hairlossfight

LJS · Post by **LJS** » Thu Nov 06, 2014 9:25 pm

I ordered my Theradome helmet a few months ago. It finally arrived 3 days ago. In these 3 days I have done 4 calls to customer service. I can't say if the thing will work to thicken hair and awake dormant follicles because out of the box IT DOES NOT WORK AT ALL. It does not charge properly. I got so many different error messages, and the customer reps don't even know anything about the product. They keep telling me they will have tech support call me back "in a couple of days" ridiculous, so I asked for my money back, and then they said they'd have a service supervisor call me back..... "in a couple of days." I'm so angry right now I just want to smash the damn thing. What a piece of crap. What a waste of money. What a scam. Live and learn, I guess.... I suppose I'll just stick with my bio-identical, minor, vitamins/herbs and healthy ways. Let's see if I have to get a lawyer friend to call them to get an RA and then get my money back. If anyone on this forum has had good results, let me know, OK? I haven't found anything anywhere to prove it really works, only horror stories of shedding. And yes, I researched it months ago and found nothing negative. But maybe that was before they all got shipped out. Thanks y'all.

LJS · Post by **LJS** » Wed Nov 12, 2014 3:57 pm

Update: After multiple screamy calls with Mark Simon, alleged Customer Service Manager for Theradome, he sent me an RA but NOT a return shipping label. So I paid for ground UPS, no insurance. F*em. He said it would take 6 weeks for refund to be processed. As soon as I get proof of delivery I'm going to lean on them HARD. It should not take more than 10 biz days for a refund. This is such a scam, folks. AVOID.

LJS · Post by **LJS** » Wed Dec 03, 2014 7:19 pm

Final update: Got my refund in 8 biz days, after threatening a law suit for credit card fraud.

doke30 · Post by **doke30** » Sat Dec 13, 2014 7:42 am

Its a real shame that this company has poor quality control on there laser helmet and poor customer service,with apira science igrow although I bought mine for only £250 om ebay still sent me a free replacement power lead and plug from usa and I live in uk did not pay a thing.
And the pictures Jacob as I see them show shiny head baldness and the after its all regrown which as I said would be a miracle at this time.
Really theradome should be doing very well if the pics are true but let down by poor quality please theradome come back here and offer us a beter product we can rely on and explain yourselves?

doke30 · Post by **doke30** » Sat Dec 13, 2014 7:44 am

I forgot to add theradome or tarrid please if you have faith in your product let us all at hairlossfight have a trial and half price offer?

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