TRULIGHT 5520 AND TRULIGHT 5320

TRULIGHT 5520 AND TRULIGHT 5320 is an FDA 510(k)-cleared medical device (K102758) manufactured by Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg. 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 October 25, 2010. Regulation: 8.