
Candela Laser Corp.
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CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR is an FDA 510(k)-cleared medical device (K934706) 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 April 28, 1994. Regulation: 8.