CANDELA CBEAM PULSE DYE LASER SYSTEM

CANDELA CBEAM PULSE DYE LASER SYSTEM is an FDA 510(k)-cleared medical device (K033331) 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 15, 2004. Regulation: 8.