The following data is part of a premarket notification filed by M&t Srl with the FDA for Mt One.
| Device ID | K192856 |
| 510k Number | K192856 |
| Device Name: | MT One |
| Classification | Powered Laser Surgical Instrument |
| Applicant | M&T SRL Via Pietrarubbia, 32/F Rimini, IT 47900 |
| Contact | Fiorenzo Rossi |
| Correspondent | Chiara Violini Endo Engineering Via Del Consorzio, 41 Falconara Marittaima, IT 60015 |
| Product Code | GEX |
| Subsequent Product Code | ONE |
| Subsequent Product Code | ONF |
| Subsequent Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-04 |
| Decision Date | 2020-04-24 |