
Candela Corp.
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CANDELA GENTLE LASE FAMILY OF LASER SYSTEM is an FDA 510(k)-cleared medical device (K024371) 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 March 30, 2003. Regulation: 8.