ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002

ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 is an FDA 510(k)-cleared medical device (K030338) manufactured by Curelight, 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 February 11, 2003. Regulation: 8.