# K181740: ZELTIQ CoolSculpting System

- Pathway: 510(k) (Traditional)
- Applicant: Zeltiq Aesthetics, Inc.
- Decided: Aug 29, 2018 after 58 days
- Product code: OOK (Dermal Cooling Pack/Vacuum/Massager)
- Device class: 2
- Regulation: 21 CFR 878.4340
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 136 ancestors in all.
No later device cites it as a predicate yet.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172144: CoolSculpting System, Zeltiq Aesthetics (2017) Summary page 4.

## Recalls of this device
- Jun 9, 2022 · Class II · Z-1349-2022: Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
- Jun 9, 2022 · Class II · Z-1347-2022: Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
- Jun 9, 2022 · Class II · Z-1350-2022: Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
- Jun 9, 2022 · Class II · Z-1346-2022: Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
- Jun 9, 2022 · Class II · Z-1348-2022: Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.

## Indications for use
The CoolSculpting System is a skin cooling or heating device. The device is 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. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is 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. Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological treatments and act as a local anesthetic for procedures that induce minor local discomfort. The CoolSculpting System is also indicated for use to provide localized thermal therapy (hot or cold) to minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of cellulite. The ZELTIQ Pretreatment Skin Wipe and Gel/Gelpad 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/K181740
Methodology: https://510kreport.com/methodology