Trios™ VTR0110
by Viora Ltd
Trios™ VTR0110 is a Class II device made by Viora Ltd, cleared under FDA 510(k) K090399 on 10 Jun 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07290016746358), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016746358 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090399 | Date10 Jun 2009 | StatusActive |
Official records
- AccessGUDID record 07290016746358
- FDA 510(k) database K090399
Across registries
- FDA 510(k) K090399 decided 10 Jun 2009 Active
- FDA GUDID UDI-DI 07290016746358 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K090399
- Listed FDA GUDID 07290016746358
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trios™
- Generic name
- Intense pulsed light skin surface treatment system
- Model / Ref / Catalog
- VTR0110
- Primary DI / UDI-DI
- 07290016746358
- 510(k) Number
- FDA product code
- ONF
- GMDN term
- Intense pulsed light skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).
- Forma FS10000 by FORMATK SYSTEMS LTD
- SHASER V-MINI HAIR REMOVAL SYSTEM by Shaser, Inc.
- HR650 applicator AS120031 by Venus Concept Inc.
- ME HAIR2GO by SYNERON MEDICAL LTD
- LUMENA FH HAIR REMOVAL SYSTEM by Shaser, Inc.
- ACDUAL applicator AS120058 by Venus Concept Inc.
- IPL Therapy Machine by Beijing ADSS Development Co., Ltd.
- IPL + Diode Laser Machine by BEIJING GLOBALIPL DEVELOPMENT CO., LTD.
- DEKA LOTUS by El.En S.P.A.
- B-HR* FS10007 by FORMATK SYSTEMS LTD