COOL-TIP RF ABLATION SYSTEM

COOL-TIP RF ABLATION SYSTEM is an FDA 510(k)-cleared medical device (K042216) manufactured by Valleylab. 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 November 11, 2004. Regulation: 8.