CANDELA GENTLELASE GL DERMATOLOGICAL LASER

CANDELA GENTLELASE GL DERMATOLOGICAL LASER is an FDA 510(k)-cleared medical device (K974381) manufactured by Candela Corp.. 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 9, 1998. Regulation: 8.