Device details
FDA 510(k) registration fields
- K number
- K231901
- Device name
- Hakon, Hakon Smart
- Country / region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-28
- Decision date
- 2023-09-28
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
