# K040727: CRYO 5

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Elektromedizin GmbH
- Decided: Apr 23, 2004 after 32 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: 6 generations back to K963094 (1996). 35 ancestors in all.
48 later devices descend from it; 4 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013864: Modification to Epi-Star Surgical Laser System, M0DEL DS-60, Nidek, Inc. (2002)
- K014253: Dermachiller 4, Paradigm Trex, LLC (2002) Summary page 1.

## Most influential descendants
- K060407: Juniper Cooling Device (2006), 36 descendants of its own
- 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

## Indications for use
The Cryo 5 Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Source page: https://510kreport.com/device/K040727
Methodology: https://510kreport.com/methodology