CANDELA SCLERO LONG PULSE DYE LASER

CANDELA SCLERO LONG PULSE DYE LASER is an FDA 510(k)-cleared medical device (K993671) 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 January 23, 2000. Regulation: 8.