Lustre PR7001
by Shenzhen Kaiyan Medical Equipment Co, . Ltd
Lustre PR7001 is a Class II device made by Shenzhen Kaiyan Medical Equipment Co, . Ltd, listed in FDA GUDID since 6 Mar 2025 (UDI-DI 05060282690325), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060282690325 | Date6 Mar 2025 | StatusListed |
Official records
- AccessGUDID record 05060282690325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Lustre
- Generic name
- Cosmetic red-light phototherapy system, home-use
- Model / reference
- PR7001
- Primary DI / UDI-DI
- 05060282690325
- FDA product code
- OHS, OLP
- GMDN term
- Cosmetic red-light phototherapy system, home-use
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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