
Candela Laser Corp.
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PLTL-1 & PLDL-1 510NM PULSED DYE LASERS is an FDA 510(k)-cleared medical device (K934811) 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 August 31, 1994. Regulation: 8.