# K233416: Cryojet Plus (SHE-ACP001-1)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sano Laser S&T Development Co.,Ltd
- Decided: Feb 6, 2024 after 119 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: 9 generations back to K963094 (1996). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220020: Cryo 7, Zimmer Medizinsysteme GmbH (2022) Summary page 5.

## Most influential descendants
- K261674: Skin Air Cooling System (QALF-01) (2026), 0 descendants of its own

## Indications for use
Cryojet Plus 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/K233416
Methodology: https://510kreport.com/methodology