Device details
FDA 510(k) registration fields
- K number
- K240604
- Device name
- MTONE EVO (MTONE EVO)
- Company
- M&T S.R.L.
- Country / region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-03-04
- Decision date
- 2024-09-20
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatmentPigment treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
