CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE

CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE is an FDA 510(k)-cleared medical device (K954934) 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 February 1, 1996. Regulation: 8.