Xemis Bl-10
by Xemis Medical Technology (Shenzhen) Co., Ltd.
Xemis Bl-10 is a Class II device made by Xemis Medical Technology (Shenzhen) Co., Ltd., cleared under FDA 510(k) K243993 on 13 Mar 2025 and listed in FDA GUDID since 3 Apr 2025 (UDI-DI 06977593370114), 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 | Number06977593370114 | Date3 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243993 | Date13 Mar 2025 | StatusActive |
Official records
- AccessGUDID record 06977593370114
- FDA 510(k) database K243993
Across registries
- FDA 510(k) K243993 decided 13 Mar 2025 Active
- FDA GUDID UDI-DI 06977593370114 listed 3 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K243993
- Listed FDA GUDID 06977593370114
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Xemis
- Generic name
- Cosmetic red-light phototherapy system, professional
- Model / reference
- BL-10
- Primary DI / UDI-DI
- 06977593370114
- 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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