The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Quanta System Surgical Laser Fibers.
| Device ID | K160513 |
| 510k Number | K160513 |
| Device Name: | Quanta System Surgical Laser Fibers |
| Classification | Powered Laser Surgical Instrument |
| Applicant | QUANTA SYSTEM SPA VIA IV NOVEMBRE, 116 Solbiate Olona (va), IT 21058 |
| Contact | Francesco Dell'antonio |
| Correspondent | Francesco Dell'antonio QUANTA SYSTEM SPA VIA IV NOVEMBRE, 116 Solbiate Olona (va), IT 21058 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-03-18 |
| Summary: | summary |