JOULE 810/940/980 MULTI-PLATFORM SYSTEM

JOULE 810/940/980 MULTI-PLATFORM SYSTEM is an FDA 510(k)-cleared medical device (K122567) manufactured by Sciton, 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 18, 2013. Regulation: 8.