Device details
FDA 510(k) registration fields
- K number
- K241656
- Device name
- Eneka Selectif
- Company
- Termosalud
- Country / region
- Spain(ES)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-06-10
- Decision date
- 2024-08-12
- Submission type
- Traditional
- Technology type
- Alexandrite(AI inferred)
- Clinical applications
- Hair removalPigment treatment
- Primary application
- Hair removal
- Classification source
- AI classified
