JOULE 1064nm System and Accessories

JOULE 1064nm System and Accessories is an FDA 510(k)-cleared medical device (K251077) 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 December 18, 2025. Regulation: 8.