The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Fiber Dust Pro.
| Device ID | K220426 |
| 510k Number | K220426 |
| Device Name: | Fiber Dust PRO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System Spa Via Acquedotto, 109 Samarate, IT 21017 |
| Contact | Dario Bandiera |
| Correspondent | Dario Bandiera Quanta System Spa Via Acquedotto, 109 Samarate, 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 | 2022-02-14 |
| Decision Date | 2022-03-16 |