SERF ABLATION SYSTEM SERF ABLATION NEEDLE

SERF ABLATION SYSTEM SERF ABLATION NEEDLE is an FDA 510(k)-cleared medical device (K120116) manufactured by Thermedical. 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 September 30, 2012. Regulation: 8.