# K233732: CoolSculpting Elite System

- Pathway: 510(k) (Traditional)
- Applicant: Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
- Decided: Sep 12, 2024 after 296 days
- Product code: OOK (Dermal Cooling Pack/Vacuum/Massager)
- Device class: 2
- Regulation: 21 CFR 878.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K183514 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212707: CoolSculpting Elite System, Zeltiq Aesthetics, Inc. (2021) Summary page 5.

## Indications for use
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, back 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, back 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.

Source page: https://510kreport.com/device/K233732
Methodology: https://510kreport.com/methodology