FDA WARNING_LETTER - Lexington International, LLC - November 09, 2007

An FDA inspection of Lexington International, LLC in Boca Raton, Florida, from November 7-9, 2007, identified significant violations regarding their HairMax LaserComb? Premium and SE models, which are classified as medical devices. The inspection revealed the devices are adulterated under section 501(f)(1)(B) of the Act due to the absence of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. Additionally, the devices were found to be misbranded under section 502(o) for failing to submit a 510(k) premarket notification. The FDA noted that the Premium and SE models feature significant changes in dose rate, delivery method, and treatment parameters compared to the previously cleared HairMax LaserComb, thus requiring new 510(k) submissions per 21 CFR 807.81(a)(3)(i). Furthermore, the firm's website promoted the device for hair growth in women, a use for which it lacks FDA clearance, as the cleared device is only indicated for males with specific androgenetic alopecia classifications. Lexington International, LLC must promptly correct these violations and provide a written response to the FDA within fifteen working days, detailing corrective actions, including those for devices in the marketplace and their websites. Failure to comply may result in regulatory actions such as seizure, injunction, or civil money penalties, and could impact eligibility for federal contracts.