MEGABEAM LATERAL FIRE

MEGABEAM LATERAL FIRE is an FDA 510(k)-cleared medical device (K943527) 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 December 4, 1994. Regulation: 8.