CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS

CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS is an FDA 510(k)-cleared medical device (K133283) 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 December 25, 2013. Regulation: 8.