FDA WARNING_LETTER - Sunetics International Corporation - August 07, 2008

The FDA issued a Warning Letter to Sunetics International Corporation for marketing the Sunetics Laser Hair Brush and Sunetics Laser Skin Brush (aka Laser Skin Therapy System) in the U.S. without marketing clearance or approval. These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act, intended for uses such as hair growth and treating various skin conditions, as advertised on the firm's website. The devices are deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), as Class III devices lacking an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE). Additionally, they are misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), due to the firm's failure to submit a 510(k) premarket notification. Although a 510(k) for the Laser Hair Brush was submitted, commercial distribution before FDA clearance is a violation. Sunetics must promptly correct these violations and provide a written response within fifteen working days detailing corrective actions and a prevention plan. Failure to comply may result in regulatory actions including seizure, injunction, and civil money penalties. The letter clarifies that it addresses only premarket review issues.