THERMAGE THERMACOOL COUPLING FLUID

THERMAGE THERMACOOL COUPLING FLUID is an FDA 510(k)-cleared medical device (K051710) manufactured by Thermage, 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 July 18, 2005. Regulation: 8.