ZELTIQ AESTHETICS DERMAL COOLING DEVICE

ZELTIQ AESTHETICS DERMAL COOLING DEVICE is an FDA 510(k)-cleared medical device (DEN090002) manufactured by Zeltiq Aesthetics. 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 August 23, 2010. Regulation: 8.