
Candela Corp.
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INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM is an FDA 510(k)-cleared medical device (K071469) 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 August 14, 2007. Regulation: 8.