Device details
FDA 510(k) registration fields
- K number
- K221635
- Device name
- IPL sapphire ice cooling hair remove device
- Country / region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-06-06
- Decision date
- 2022-08-31
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- Body
- Primary application
- Body
- Classification source
- AI classified
