# K261674: Skin Air Cooling System (QALF-01)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Nubway S&T Co., Ltd.
- Decided: Jul 16, 2026 after 56 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: 10 generations back to K963094 (1996). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233416: Cryojet Plus (SHE-ACP001-1), Beijing Sano Laser S&T Development Co.,Ltd (2024) Summary page 6.
- K220020: Cryo 7, Zimmer Medizinsysteme GmbH (2022) Summary page 6.

## Indications for use
Skin Air Cooling System is indicated to be used 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/K261674
Methodology: https://510kreport.com/methodology