NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES

NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES is an FDA 510(k)-cleared medical device (K052526) manufactured by Lumenis, 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 November 14, 2005. Regulation: 8.