Device details
FDA 510(k) registration fields
- K number
- K221766
- Device name
- Solon
- Country / region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-06-17
- Decision date
- 2024-01-05
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingSkin tighteningHair removal
- Primary application
- Hair removal
- Classification source
- AI classified
