LUME 2 SYSTEM, MODEL GA0005000

LUME 2 SYSTEM, MODEL GA0005000 is an FDA 510(k)-cleared medical device (K083733) manufactured by Lumenis, 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 May 3, 2009. Regulation: 8.