# K072152: Juniper CLN1 Dermal Cooling Device

- Pathway: 510(k) (Traditional)
- Applicant: Juniper Medical, Inc.
- Decided: Sep 7, 2007 after 35 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K943450 (1995). 119 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060407: Juniper Cooling Device, Juniper Medical Technology, Inc. (2006) Summary page 1.
- K063715: Juniper Cooling Device Xtra, Juniper Medical, Inc. (2007) Summary page 1.
- K023231: Elfcare Device, Models 314A Through 314G, Mediseb, Ltd. (2003) Summary page 1.
- K030876: Cynosure Triactive Therapeutic Massage System, Cynosure, Inc. (2004) Summary page 1.
- K051710: Thermage Thermacool Coupling Fluid, Thermage, Inc. (2005) Summary page 1.

## Most influential descendants
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own
- 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

## Indications for use
The Juniper CLNl 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 Juniper CLNl 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 relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite. The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-to-skin contact.

Source page: https://510kreport.com/device/K072152
Methodology: https://510kreport.com/methodology