FDA WARNING_LETTER - Gaunitz Hair Sciences, LLC - August 07, 2008

On August 7, 2008, the FDA issued a Warning Letter to Gaunitz Hair Sciences, LLC for marketing the THL-1™ Handheld Laser without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The device is intended for medical uses like hair growth, healing the scalp, treating acne, diabetic neuropathy, and wound healing, making it subject to FDA regulations.

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the firm's websites (gaunitzlaser.com and hairgrowthcenters.com) on August 5, 2008, which promoted the THL-1™ as a "healing laser" for various medical conditions.

The THL-1™ Handheld Laser is deemed adulterated under section 501(f)(1)(B) of the Act because no approved premarket approval (PMA) or investigational device exemption (IDE) application is in effect. It is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k).

Gaunitz Hair Sciences, LLC must take prompt action to correct these violations. Failure to comply may result in regulatory actions such as seizure, injunction, or civil money penalties. Federal agencies are also advised of Warning Letters, which may impact contract awards.