Vellus HYPER HR
by Shenzhen Leaflife Technology Co., Ltd.
Vellus HYPER HR is a dermatological diode laser system (FDA Class II; FDA product code OHT, Light Based Over-The-Counter Hair Removal) made by Shenzhen Leaflife Technology Co., Ltd., cleared under FDA 510(k) K220103 on 12 Apr 2022 and listed in FDA GUDID since 10 Mar 2023 (UDI-DI 06974223650103), 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 | GUDID listing | Number06974223650103 | Date10 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220103 | Date12 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 06974223650103
- FDA 510(k) database K220103
Across registries
- FDA 510(k) K220103 decided 12 Apr 2022 Active
- FDA GUDID UDI-DI 06974223650103 listed 10 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K220103
- Listed FDA GUDID 06974223650103
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vellus
- Generic name
- Dermatological diode laser system
- Model / reference
- HYPER HR
- Primary DI / UDI-DI
- 06974223650103
- 510(k) Number
- FDA product code
- OHT
- GMDN term
- Dermatological diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Dermatological diode laser system.
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