Cryocare CS-3 Surgical System version 5

Cryocare CS-3 Surgical System version 5 is an FDA 510(k)-cleared medical device (K151968) manufactured by Healthtronics. 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 8, 2015. Regulation: 8.