SPPHINE PLUS STM 3W DIODE LASER

SPPHINE PLUS STM 3W DIODE LASER is an FDA 510(k)-cleared medical device (K110079) manufactured by Den-Mat Holdings, LLC. 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 9, 2011. Regulation: 8.