FDA Warns HairMax LaserComb Makers About Illegal Sales of Non-FDA Cleared Devices

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Los Angeles - U.S. Regulators have warned Lexington International, the makers of the highly touted and controversial HairMax LaserComb, to shape up or ship out.

In an FDA warning letter issued to David Michaels, Managing Director of Lexington International, LLC on May 22, 2008, FDA inspectors cite that the HairMax LaserComb® Premium and SE models, that are currently being sold to the public, differ from the cleared HairMax LaserComb in dose rate, method of delivery, and/or treatment parameters. According to the FDA these changes could significantly affect the safety or effectiveness of these devices and therefore, pursuant to 21, CFR 807.81 (a)(3)(i), new 510(k) submissions are required in order to legally market these devices.

Interestingly enough HairMax LaserComb makers warn consumers about purchasing fraudulent, or less than effective laser devices on their own marketing website. [Read more]

Where Are The HairMax Lasercomb Studies?

Dear Spencer,

Months ago when you interviewed David Michaels, one of the inventors of the HairMax Lasercomb, he said that he was going to give you a copy of the study that Lexington presented to the FDA in order for the Lasercomb to gain market clearance, did you ever see the study, and if so what were your thoughts or any experts thoughts on it? - Chris

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Dear Chris,

I never did receive that study. The truth is I still haven’t seen any substantial evidence that the HairMax Lasercomb can effectively treat hair loss to any appreciable degree. I’m still waiting.

Regards,

Spencer Kobren

Host of The Bald Truth Radio Show
Founder, American Hair Loss Association
Founder and Director of Consumer/Patient Affairs, International Alliance of Hair Restoration Surgeons (IAHRS.ORG)

David Michaels Defends The Efficacy of The Laser Comb

Hairmax Laser Comb inventor talks With Spencer Kobren about several controversial topics surrounding the Laser Comb device, including the FDA clearance.
Part One

Part Two