# K052310: Cryoflow 700, Cryoflow 1000

- Pathway: 510(k) (Abbreviated)
- Applicant: Uniphy Elektromedizin GmbH & Co. KG
- Decided: Mar 15, 2006 after 203 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.
No later device cites it as a predicate yet.
0 of 37 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.

## Indications for use
The Cryoflow 700 and Cryoflow 1000 are 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/K052310
Methodology: https://510kreport.com/methodology