180W CERELAS D 980NM DIODE LASER, MODEL D180

180W CERELAS D 980NM DIODE LASER, MODEL D180 is an FDA 510(k)-cleared medical device (K083682) manufactured by Biolitec, Inc.. 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 January 8, 2009. Regulation: 8.