RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012

RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 is an FDA 510(k)-cleared medical device (K033183) 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 April 14, 2004. Regulation: 8.