
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
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CoolSculpting Elite System is an FDA 510(k)-cleared medical device (K233732) manufactured by Zeltiq Aesthetics, Inc. (Acquired by Allergan 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 September 11, 2024. Regulation: 8.