# K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device

- Pathway: 510(k) (Traditional)
- Applicant: Zeltiq Aesthetics
- Decided: May 2, 2008 after 106 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: 14 generations back to K943450 (1995). 125 ancestors in all.
33 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)
- K072152: Juniper CLN1 Dermal Cooling Device, Juniper Medical, Inc. (2007) Summary page 1.
- K030876: Cynosure Triactive Therapeutic Massage System, Cynosure, Inc. (2004) Summary page 1.
- K992749: Ultraview Waveform Pager System, Model 91841, Spacelabs Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K090094: Zeltiq System (2009), 32 descendants of its own
- 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

## Indications for use
The Zeltiq CLN1 Dermal Cooling Device 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 CLN1 Dermal Cooling Device 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. The Zeltiq Coupling Gels facilitate thermal contact of the Zeltiq CLN1 Dermal Cooling Device with a patient's skin by mitigating minor variances in device-to-skin contact.

Source page: https://510kreport.com/device/K080118
Methodology: https://510kreport.com/methodology