CELL GEN LASER, MODEL CG-4000

CELL GEN LASER, MODEL CG-4000 is an FDA 510(k)-cleared medical device (K080084) manufactured by Cell Gen Therapeutics, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2008. Regulation: 8.