CANDELA VBEAM PULSED DYE LASER SYSTEM

CANDELA VBEAM PULSED DYE LASER SYSTEM is an FDA 510(k)-cleared medical device (K021180) 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 July 1, 2002. Regulation: 8.