Mtone Evo
by M & T SRL
Mtone Evo is a Class II device made by M & T SRL, cleared under FDA 510(k) K240604 on 20 Sep 2024 and listed in FDA GUDID since 15 Apr 2025 (UDI-DI 08057622080004), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08057622080004 | Date15 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240604 | Date20 Sep 2024 | StatusActive |
Official records
- AccessGUDID record 08057622080004
- FDA 510(k) database K240604
Across registries
- FDA 510(k) K240604 decided 20 Sep 2024 Active
- FDA GUDID UDI-DI 08057622080004 listed 15 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K240604
- Listed FDA GUDID 08057622080004
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dermatological diode laser system
- Model / reference
- MTONE EVO
- Primary DI / UDI-DI
- 08057622080004
- 510(k) Number
- FDA product code
- GEX, ONE, ONF, ONG
- GMDN term
- Dermatological diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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