# K153564: Pure Cryogen

- Pathway: 510(k) (Traditional)
- Applicant: Air Liquide Healthcare America Corporation
- Decided: Mar 29, 2016 after 106 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: 4 generations back to K904627 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001589: Candela Dynamic Cooling Device, Candela Corp. (2000) Summary page 5.

## Indications for use
PURE CRYOGEN is indicated to be used as an accessory to Candela Corporation's Dynamic Cooling Device as a source of skin refrigerant fluid. The intended use of PURE CRYOGEN is (1) cooling of the skin prior to laser treatment, (2) reduction of pain during laser treatment, (3) allows for use of higher laser fluences for laser treatments, such as for hair removal and vascular lesions, and (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions.

Source page: https://510kreport.com/device/K153564
Methodology: https://510kreport.com/methodology