HairMax LaserComb Makers Warned by the FDA About Illegal Sales of Non-FDA Cleared Devices
Laser therapy as a hair loss treatment has been heavily debated, especially since the recent FDA clearance of the HairMax LaserComb by consumers and hair restoration physicians. To participate in this discussion, visit our hair loss forum. Read more about laser hair loss treatment.
On May 22, 2008, FDA inspectors issued a warning letter to David Michaels, the Managing Director of Lexington International, LLC regarding the sale of HairMax LaserComb ® Premium and SE models that differ from the cleared HairMax LaserComb. According to the FDA, the treatment parameters, dose rate, and method of delivery in the laser comb models being sold to the public could significantly affect the safety and/or effectiveness of these laser mechanisms. Therefore, Lexington International may be subject to 21, CFR 807.81 (a)(3)(i) new 510(k) submissions in order to legally market and sell their premium and SE LaserCombs as “FDA Cleared”.
Ironically, on the HairMax website, Lexington International warns consumers about purchasing fraudulent and potentially less effective laser devices. As listed on their 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.”
Because this FDA issued warning is several months old, we are not aware if Lexington International, LLC has contacted the FDA in order to acquire the appropriate FDA clearance to market their HairMax Lasercomb ® Premium and SE Models as “FDA Cleared”.
To read the official FDA Warning letter to Lexington International, visit: http://www.fda.gov/foi/warning_letters/s6948c.htm
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