# K120023: Zeltiq Coolsculpting

- Pathway: 510(k) (Traditional)
- Applicant: Zeltiq Aesthetics, Inc.
- Decided: May 2, 2012 after 120 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: 16 generations back to K943450 (1995). 128 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN090002: Zeltiq Aesthetics Dermal Cooling Device, Zeltiq Aesthetics (2010). Our OCR of the scanned summary read K080521, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090002, Zeltiq Aesthetics Dermal Cooling Device (Zeltiq Aesthetics), granted Aug 24, 2010; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K090094: Zeltiq System, Zeltiq Aesthetics (2009) Summary page 1.

## Most influential descendants
- K133212: Zeltiq Coolsculpting System (2014), 30 descendants of its own
- K142491: ZEL TIQ CoolSculpting System (2015), 27 descendants of its own
- K151179: ZELTIQ CoolSculpting System (2015), 26 descendants of its own
- K150724: SculpSure (2015), 21 descendants of its own
- K150230: SculpSure (2015), 21 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 of the abdomen, as well as the 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 the abdomen and the 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, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite. The ZELTIQ Gelpad facilitates 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/K120023
Methodology: https://510kreport.com/methodology