# K060395: Cryo, Model V6.0

- Pathway: 510(k) (Special)
- Applicant: Zimmer Elektromedizin GmbH
- Decided: Feb 24, 2006 after 9 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: 7 generations back to K963094 (1996). 36 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040727: CRYO 5, Zimmer Elektromedizin GmbH (2004) Summary page 1.

## Most influential descendants
- K220020: Cryo 7 (2022), 2 descendants of its own
- K083008: Coolskin (2009), 2 descendants of its own
- K233416: Cryojet Plus (SHE-ACP001-1) (2024), 1 descendant of its own
- K213294: Dermal Cooling System (2022), 1 descendant of its own
- K080735: Cryomini (2008), 1 descendant of its own

## Indications for use
The Cryo V6.0 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/K060395
Methodology: https://510kreport.com/methodology