BTL-9000; BTL-9000 RADIOFREQUENCY MODULE

BTL-9000; BTL-9000 RADIOFREQUENCY MODULE is an FDA 510(k)-cleared medical device (K134040) manufactured by Btl Industries, Ltd.. 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 9, 2014. Regulation: 8.