The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Empower H35.
| Device ID | K180426 |
| 510k Number | K180426 |
| Device Name: | Empower H35 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System Spa Via Acquedotto, 109 Samarate, IT 21017 |
| Contact | Francesco Dell'antonio |
| Correspondent | Francesco Dell'antonio 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 | 2018-02-16 |
| Decision Date | 2018-03-16 |
| Summary: | summary |