CANDELA SPTL-1B PULSED DYE LASER

CANDELA SPTL-1B PULSED DYE LASER is an FDA 510(k)-cleared medical device (K001093) 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 September 18, 2000. Regulation: 8.