The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Litho 60.
| Device ID | K172025 |
| 510k Number | K172025 |
| Device Name: | Litho 60 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | quanta System Spa via Acquedotto 109 Samarate (va), IT 21017 |
| Contact | Francesco Dell' Antonio |
| Correspondent | Francesco Dell' Antonio quanta System Spa via Acquedotto 109 Samarate (va), IT 21017 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-07-31 |
| Summary: | summary |