
Candela Laser Corp.
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CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY is an FDA 510(k)-cleared medical device (K942152) manufactured by Candela Laser 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 July 24, 1994. Regulation: 8.