The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Evo Platform.
| Device ID | K160368 |
| 510k Number | K160368 |
| Device Name: | EVO Platform |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2016-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033945934217 | K160368 | 000 |
| 08033945934194 | K160368 | 000 |
| 08033945934200 | K160368 | 000 |
| 08033945934156 | K160368 | 000 |
| 08033945934088 | K160368 | 000 |
| 08033945934095 | K160368 | 000 |
| 08033945934101 | K160368 | 000 |
| 08033945934118 | K160368 | 000 |
| 08033945934125 | K160368 | 000 |
| 08033945934132 | K160368 | 000 |
| 08033945934163 | K160368 | 000 |
| 08033945934170 | K160368 | 000 |
| 08033945934187 | K160368 | 000 |
| 08033945934149 | K160368 | 000 |