SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001

SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 is an FDA 510(k)-cleared medical device (K071180) manufactured by Engineered Medical Solutions Co., LLC. 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 June 19, 2007. Regulation: 8.