RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT

RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT is an FDA 510(k)-cleared medical device (K051268) manufactured by Radiancy, Ltd.. 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 July 5, 2005. Regulation: 8.