FDA Warns HairMax LaserComb Makers About Illegal Sales of Non-FDA Cleared Devices
October 15, 2008 by Spencer Kobren
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.
Here’s what it states on the HairMax website:
As a consumer, we suggest that you educate yourself thoroughly before making a purchase or utilizing a laser device. Make no mistake: Using lasers for any reason is a very serious medical undertaking which, if not administered under proper safety guidelines, can be risky. At best, you may be buying a laser device and spending time using it, only to receive minimal if any results.
Again, at Lexington we care about your safety and your right to be educated as a consumer.
And remember: CAVEAT EMPTOR; BUYER BEWARE.
Included on their website is an FDA warning Letter issued to a competitor just two months before U.S. Regulators issued a warning to Lexington International, LLC.
The American Hair Loss Association does not currently recommend the HairMax LaserComb for the prevention and treatment of hair loss.
Caveat Emptor Indeed.
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)
**Please also be aware that this letter was issued on May 22, 2008, and at this time we do not know if Lexington International, LLC has since acquired the appropriate FDA clearance to market and sell the HairMax LaserComb® Premium and SE models.
To Read FDA Warning Letter Visit: