Kernel KN-7000L
by Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel KN-7000L is a Class II device made by Xuzhou Kernel Medical Equipment Co., Ltd., cleared under FDA 510(k) K222751 on 1 Feb 2023 and listed in FDA GUDID since 28 Feb 2023 (UDI-DI 06928798600513), 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 | Number06928798600513 | Date28 Feb 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222751 | Date1 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 06928798600513
- FDA 510(k) database K222751
Across registries
- FDA 510(k) K222751 decided 1 Feb 2023 Active
- FDA GUDID UDI-DI 06928798600513 listed 28 Feb 2023 Listed
Timeline
- Cleared FDA 510(k) K222751
- Listed FDA GUDID 06928798600513
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kernel
- Generic name
- Cosmetic red-light phototherapy system, professional
- Model / reference
- KN-7000L
- Primary DI / UDI-DI
- 06928798600513
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Cosmetic red-light phototherapy system, professional
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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