The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Quanta Forte.
| Device ID | K152714 |
| 510k Number | K152714 |
| Device Name: | Quanta Forte |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033945934750 | K152714 | 000 |
| 08033945938406 | K152714 | 000 |
| 08033945934651 | K152714 | 000 |
| 08033945934668 | K152714 | 000 |
| 08033945934675 | K152714 | 000 |
| 08033945934682 | K152714 | 000 |
| 08033945934699 | K152714 | 000 |
| 08033945934705 | K152714 | 000 |
| 08033945934712 | K152714 | 000 |
| 08033945934729 | K152714 | 000 |
| 08033945934743 | K152714 | 000 |
| 08033945934736 | K152714 | 000 |