The following data is part of a premarket notification filed by Quanta System S.p.a. with the FDA for Thunder, Thunder Vt, Thunder Hr.
| Device ID | K171711 |
| 510k Number | K171711 |
| Device Name: | Thunder, Thunder VT, Thunder HR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System S.p.A. Via Acquedotto, 109 Samarate, IT 20826 |
| Contact | Francesco Dell'antonio |
| Correspondent | Francesco Dell'antonio Quanta System S.p.A. Via Acquedotto, 109 Samarate, IT 20826 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-09 |
| Decision Date | 2017-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033945936983 | K171711 | 000 |
| 08033945936976 | K171711 | 000 |
| 08033945936969 | K171711 | 000 |
| 08033945936952 | K171711 | 000 |