MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE

MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE is an FDA 510(k)-cleared medical device (K020099) 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 April 10, 2002. Regulation: 8.