CERALAS D LASER SYSTEM, MODEL # CERALAS D15

CERALAS D LASER SYSTEM, MODEL # CERALAS D15 is an FDA 510(k)-cleared medical device (K983058) manufactured by Ceram Optec, 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 October 20, 1998. Regulation: 8.