TIVAMED COOLED RF SYSTEM, MODEL 78001

TIVAMED COOLED RF SYSTEM, MODEL 78001 is an FDA 510(k)-cleared medical device (K082962) manufactured by Tivamed, 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 December 3, 2008. Regulation: 8.