
Thermigen, L.L.C
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ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is an FDA 510(k)-cleared medical device (K173582) manufactured by Thermigen, L.L.C. 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 January 16, 2018. Regulation: 8.