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- Thu May 01, 2014 3:06 pm
- Forum: Low Level Laser Therapy (LLLT) for Hair Loss
- Topic: Theradome™ Laser Helmet
- Replies: 47
- Views: 74522
Re: Theradome™ Laser Helmet
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 La...