THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES

THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES is an FDA 510(k)-cleared medical device (K090580) manufactured by Solta Medical, 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 June 25, 2009. Regulation: 8.