CERALAS D DIODE LASER SYSTEM, MODEL # D50

CERALAS D DIODE LASER SYSTEM, MODEL # D50 is an FDA 510(k)-cleared medical device (K013691) 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 August 12, 2002. Regulation: 8.