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Valleylab
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COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES is an FDA 510(k)-cleared medical device (K053290) 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 March 14, 2006. Regulation: 8.