Zeltiq Aesthetics Cln1 Dermal Cooling Device

K080118 is the FDA 510(k) clearance record for ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE, a class II device, cleared for Zeltiq Aesthetics on 2008-05-02 under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 17 510(k) clearances for Zeltiq Aesthetics, from 2008-05-02 to 2024-02-01. As of 2026-09-10, FDA records show no recalls naming K080118.