EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX is an FDA 510(k)-cleared medical device (K120857) manufactured by Ncontact Surgical, 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 12, 2012. Regulation: 8.