CANDELA GENTLEMAX FAMILY OF LASERS

CANDELA GENTLEMAX FAMILY OF LASERS is an FDA 510(k)-cleared medical device (K112715) 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 October 4, 2011. Regulation: 8.