MolecuLightDX System 2094
MolecuLightDX System 2094 is a Class II device made by MolecuLight Inc, cleared under FDA 510(k) K211901 on 21 Jul 2021 and listed in FDA GUDID since 4 Jan 2022 (UDI-DI 00628110259387), 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 | Number00628110259387 | Date4 Jan 2022 | StatusListed |
| United States | FDA 510(k) | NumberK211901 | Date21 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 00628110259387
- FDA 510(k) database K211901
Across registries
- FDA 510(k) K211901 decided 21 Jul 2021 Active
- FDA GUDID UDI-DI 00628110259387 listed 4 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K211901
- Listed FDA GUDID 00628110259387
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MolecuLightDX System
- Generic name
- Fluorescence wound imaging unit
- Model / reference
- 2094
- Primary DI / UDI-DI
- 00628110259387
- 510(k) Number
- FDA product code
- QJF
- GMDN term
- Fluorescence wound imaging unit
- Device class
- Class II
- Regulation number
- 878.4550
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds).