TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC

TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC is an FDA 510(k)-cleared medical device (K090312) manufactured by Tria Beauty, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2010. Regulation: 8.