The following data is part of a premarket notification filed by Viora Ltd. with the FDA for Trios System.
| Device ID | K090399 |
| 510k Number | K090399 |
| Device Name: | TRIOS SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | VIORA LTD. 30 MONTGOMERY STREET SUITE 660 Jersey City, NJ 07302 |
| Contact | Josef Luzon |
| Correspondent | Josef Luzon VIORA LTD. 30 MONTGOMERY STREET SUITE 660 Jersey City, NJ 07302 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016746396 | K090399 | 000 |
| 07290016746389 | K090399 | 000 |
| 07290016746365 | K090399 | 000 |
| 07290016746358 | K090399 | 000 |