HR Hand piece VTR2001
by Viora Ltd
HR Hand piece VTR2001 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 07290016746365), 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 | Number07290016746365 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090399 | Date10 Jun 2009 | StatusActive |
Official records
- AccessGUDID record 07290016746365
- FDA 510(k) database K090399
Across registries
- FDA 510(k) K090399 decided 10 Jun 2009 Active
- FDA GUDID UDI-DI 07290016746365 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K090399
- Listed FDA GUDID 07290016746365
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HR Hand piece
- Generic name
- Intense pulsed light skin surface treatment system
- Model / Ref / Catalog
- VTR2001
- Primary DI / UDI-DI
- 07290016746365
- 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
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