E-Light Line LED Mask H
E-Light Line LED Mask H is a Class II device made by Espansione Marketing SpA, cleared under FDA 510(k) K092734 on 20 Sep 2010 and listed in FDA GUDID since 3 Sep 2019 (UDI-DI 08056389700071), 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 | Number08056389700071 | Date3 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092734 | Date20 Sep 2010 | StatusActive |
Official records
- AccessGUDID record 08056389700071
- FDA 510(k) database K092734
Across registries
- FDA 510(k) K092734 decided 20 Sep 2010 Active
- FDA GUDID UDI-DI 08056389700071 listed 3 Sep 2019 Listed
Timeline
- Cleared FDA 510(k) K092734
- Listed FDA GUDID 08056389700071
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- E-Light Line
- Generic name
- Multi-modality skin surface treatment system
- Model / Ref / Catalog
- LED MASK H
- Primary DI / UDI-DI
- 08056389700071
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Multi-modality skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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