The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Litho Evo.
| Device ID | K192990 |
| 510k Number | K192990 |
| Device Name: | Litho Evo |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-25 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08059173390960 | K192990 | 000 |