CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) is an FDA 510(k)-cleared medical device (K013748) 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 February 10, 2002. Regulation: 8.