Trios System
by Viora Ltd
510(k) K090399
Trios System is a medical device (FDA Class II; FDA product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect) made by Viora Ltd, cleared under FDA 510(k) K090399 on 10 Jun 2009, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090399 | Date10 Jun 2009 | StatusActive |
Official records
- FDA 510(k) database K090399
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ONF
- FDA applicant
- Viora , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K090399
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AC Hand piece VTR2003 | VTR2003 / VTR2003 | 07290016746396 | — | On the market |
| HR Hand piece VTR2001 | VTR2001 / VTR2001 | 07290016746365 | — | On the market |
| SR Hand piece VTR2002 | VTR2002 / VTR2002 | 07290016746389 | — | On the market |
| Trios™ VTR0110 | VTR0110 / VTR0110 | 07290016746358 | — | On the market |
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