
Ncontact Surgical, Inc.
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EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX is an FDA 510(k)-cleared medical device (K142084) 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 October 27, 2014. Regulation: 8.