CANDELA CLEARBEAM PULSED DYE LASER

CANDELA CLEARBEAM PULSED DYE LASER is an FDA 510(k)-cleared medical device (K013043) 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 October 10, 2001. Regulation: 8.