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 ›