The following data is part of a premarket notification filed by M&t S.r.l with the FDA for Mt One.
| Device ID | K172413 |
| 510k Number | K172413 |
| Device Name: | MT ONE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | M&T S.R.L Via Pietrarubbia, 32/F Rimini, IT |
| Contact | Fiorenzo Rossi |
| Correspondent | Chiara Violini Endo Engineering S.r.l. via Del Consorzio, 41 Falconara Marittima, IT |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2017-10-06 |
| Summary: | summary |