Virtue RF
Virtue RF is a radio-frequency skin surface treatment system (FDA Class II; FDA product code OUH, Skin Resurfacing Rf Applicator) made by shenb Co., Ltd., cleared under FDA 510(k) K150409 on 15 Jan 2016 and listed in FDA GUDID since 10 Dec 2020 (UDI-DI 08800017100715), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800017100715 | Date10 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150409 | Date15 Jan 2016 | StatusActive |
Official records
- AccessGUDID record 08800017100715
- FDA 510(k) database K150409
Across registries
- FDA 510(k) K150409 decided 15 Jan 2016 Active
- FDA GUDID UDI-DI 08800017100715 listed 10 Dec 2020 Listed
Recalls
-
- Terminated Z-0444-2021
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Timeline
- Cleared FDA 510(k) K150409
- Recall initiated FDA recalls Z-0444-2021
- Listed FDA GUDID 08800017100715
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radio-frequency skin surface treatment system
- Model / reference
- Virtue RF
- Primary DI / UDI-DI
- 08800017100715
- 510(k) Number
- FDA product code
- OUH
- GMDN term
- Radio-frequency skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radio-frequency skin surface treatment system.