# K090094: Zeltiq System

- Pathway: 510(k) (Special)
- Applicant: Zeltiq Aesthetics
- Decided: May 20, 2009 after 126 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 126 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device, Zeltiq Aesthetics (2008) Summary page 1.

## Most influential descendants
- K120023: Zeltiq Coolsculpting (2012), 31 descendants of its own
- 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

## Indications for use
The Zeltiq System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and 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. Zeltiq Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.

Source page: https://510kreport.com/device/K090094
Methodology: https://510kreport.com/methodology