CERALAS DIODE LASER SYSTEM (MODEL H)

CERALAS DIODE LASER SYSTEM (MODEL H) is an FDA 510(k)-cleared medical device (K983950) 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 February 2, 1999. Regulation: 8.