SHARPLAN SMOKE EVACUATION UNIT, MODEL 100

SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 is an FDA 510(k)-cleared medical device (K894765) manufactured by Laser Industries , Ltd.. 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 September 27, 1989. Regulation: 8.