LINSCAN 808, LINSCAN 980

LINSCAN 808, LINSCAN 980 is an FDA 510(k)-cleared medical device (K141063) manufactured by Gme (German Medical Engineering) GmbH. 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 July 14, 2014. Regulation: 8.