# K060407: Juniper Cooling Device

- Pathway: 510(k) (Traditional)
- Applicant: Juniper Medical Technology, Inc.
- Decided: May 31, 2006 after 104 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: 9 generations back to K910422 (1992). 77 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014253: Dermachiller 4, Paradigm Trex, LLC (2002) Summary page 1.
- K040727: CRYO 5, Zimmer Elektromedizin GmbH (2004) Summary page 1.
- K050047: Cutera Optional Pulsed Light Hand Piece Family, Cutera, Inc. (2005) Summary page 1.
- K030235: F1 Diode Laser System, Opus Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- 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

## Indications for use
The Juniper 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.

Source page: https://510kreport.com/device/K060407
Methodology: https://510kreport.com/methodology