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The CoolSculpting Elite System is a skin cooling or heating device. It can be used in cooling or heating mode. Cooling Mode • Indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, banana roll, thigh, abdomen, and flank (or "love handles") in individuals with a Body Mass Index (BMI) of 30 or less. • Intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. · Intended to affect the appearance of visible fat bulges in the upper arm, bra fat, banana roll, submental and submandibular areas, thigh, abdomen, and flank. · When used for cold-assisted lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area. - · Can be used to minimize pain and thermal injury during laser and dermatological treatments. - · Can be used as a local anesthetic for procedures that induce minor local discomfort. Heating or Cooling Mode - · Can be used to minimize pain post-trauma and post-surgery. - · Can be used to provide temporary relief of minor aches, pains, and muscle spasms. • The ZELTIQ Pretreatment Skin Wipe and gel pad facilitate thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.

The CoolSculpting Elite System is a portable thermoelectric cooling device that applies controlled cooling to a treatment site. The CoolSculpting Elite System comprises of a control unit, detachable applicators, and accessories such as cycle cards, CoolAdhesive gelpads, gel traps, pretreatment skin wipes, liners, foam borders, and comfort straps. The device treats a target temperature down to -11°C with an accuracy of ±0.5°C. The device will automatically stop the treatment if the interface temperature goes past the target temperature by more than 1°C when treating below 5°C