# K160259: ZELTIQ CoolSculpting System

- Pathway: 510(k) (Traditional)
- Applicant: Zeltiq Aesthetics, Inc.
- Decided: Mar 23, 2016 after 51 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: 20 generations back to K943450 (1995). 132 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151179: ZELTIQ CoolSculpting System, Zeltiq Aesthetics, Inc. (2015) Summary page 4.

## Most influential descendants
- K162050: ZELTIQ CoolSculpting System (2016), 14 descendants of its own
- K171111: Sculpsure (2017), 10 descendants of its own
- K171992: SculpSure (2017), 8 descendants of its own
- K171069: ZELTIQ CoolSculpting System (2017), 8 descendants of its own
- K172144: CoolSculpting System (2017), 7 descendants of its own

## 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 bra fat, back fat, banana roll, submental area, thigh, abdomen, and flank, or “love handles” in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in bra fat, back fat, banana roll, submental area, thigh, abdomen and flank. 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/K160259
Methodology: https://510kreport.com/methodology