POLARIS DIODE LASER SYSTEM AND ACCESSORIES

POLARIS DIODE LASER SYSTEM AND ACCESSORIES is an FDA 510(k)-cleared medical device (K990914) manufactured by Xintec Corporation. 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 29, 1999. Regulation: 8.