CANDELA-INOLASE SERENITY PRO PSF SYSTEM

CANDELA-INOLASE SERENITY PRO PSF SYSTEM is an FDA 510(k)-cleared medical device (K072925) manufactured by Inolase, Ltd.. 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 January 9, 2008. Regulation: 8.