Lightbox L3 L300
Lightbox L3 L300 is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K212468 on 6 Jan 2022 and listed in FDA GUDID since 29 Jan 2024 (UDI-DI 00851354004509), 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 | Number00851354004509 | Date29 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212468 | Date6 Jan 2022 | StatusActive |
Official records
- AccessGUDID record 00851354004509
- FDA 510(k) database K212468
Across registries
- FDA 510(k) K212468 decided 6 Jan 2022 Active
- FDA GUDID UDI-DI 00851354004509 listed 29 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K212468
- Listed FDA GUDID 00851354004509
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lightbox L3
- Generic name
- Mechanical atherectomy system catheter, peripheral
- Model / Ref / Catalog
- L300
- Primary DI / UDI-DI
- 00851354004509
- 510(k) Number
- FDA product code
- NQQ
- GMDN term
- Mechanical atherectomy system catheter, peripheral
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
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