# K063715: Juniper Cooling Device Xtra

- Pathway: 510(k) (Traditional)
- Applicant: Juniper Medical, Inc.
- Decided: Feb 5, 2007 after 53 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: 10 generations back to K910422 (1992). 91 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 127 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.
- 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.
- K961222: Evron Gel, Pharmaceutical Innovations, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K051170: Gemini GXL, Philips Medical Systems (Cleveland), Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- 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

## Indications for use
The Juniper Cooling Device XTRA 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 Cooling Device XTRA 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 Gel facilitates thermal contact of the Juniper Cooling Device XTRA with a patient's skin by mitigating minor variances in device-to-skin contact.

Source page: https://510kreport.com/device/K063715
Methodology: https://510kreport.com/methodology