The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Surgical Laser Fibers.
| Device ID | K180158 |
| 510k Number | K180158 |
| Device Name: | Surgical Laser Fibers |
| 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 | 2018-01-19 |
| Decision Date | 2018-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033945938826 | K180158 | 000 |
| 08033945938246 | K180158 | 000 |
| 08033945938178 | K180158 | 000 |
| 08033945938147 | K180158 | 000 |
| 08033945938116 | K180158 | 000 |
| 08033945938086 | K180158 | 000 |
| 08033945937997 | K180158 | 000 |
| 08033945937966 | K180158 | 000 |
| 08033945937935 | K180158 | 000 |
| 08033945937843 | K180158 | 000 |
| 08033945937812 | K180158 | 000 |
| 08033945937720 | K180158 | 000 |
| 08033945937690 | K180158 | 000 |
| 08033945938277 | K180158 | 000 |
| 08033945938307 | K180158 | 000 |
| 08033945938819 | K180158 | 000 |
| 08033945938802 | K180158 | 000 |
| 08033945938796 | K180158 | 000 |
| 08033945938642 | K180158 | 000 |
| 08033945938772 | K180158 | 000 |
| 08033945938765 | K180158 | 000 |
| 08033945938758 | K180158 | 000 |
| 08033945938741 | K180158 | 000 |
| 08033945938451 | K180158 | 000 |
| 08033945938727 | K180158 | 000 |
| 08033945938710 | K180158 | 000 |
| 08033945938697 | K180158 | 000 |
| 08033945938703 | K180158 | 000 |