Device details
FDA 510(k) registration fields
- K number
- K233416
- Device name
- Cryojet Plus (SHE-ACP001-1)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-10-10
- Decision date
- 2024-02-06
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Skin tightening
- Primary application
- Skin tightening
- Classification source
- AI classified
