Micromed LED PHOTIC
Micromed LED PHOTIC is a Class II device made by Micromed, Inc., cleared under FDA 510(k) K211974 on 23 Sep 2021 and listed in FDA GUDID since 25 Oct 2021 (UDI-DI 08033928121184), 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 | Number08033928121184 | Date25 Oct 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211974 | Date23 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 08033928121184
- FDA 510(k) database K211974
Across registries
- FDA 510(k) K211974 decided 23 Sep 2021 Active
- FDA GUDID UDI-DI 08033928121184 listed 25 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K211974
- Listed FDA GUDID 08033928121184
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Micromed
- Generic name
- Ophthalmic flash generator
- Model / reference
- LED PHOTIC
- Primary DI / UDI-DI
- 08033928121184
- 510(k) Number
- FDA product code
- GWE
- GMDN term
- Ophthalmic flash generator
- Device class
- Class II
- Regulation number
- 882.1890
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code GWE (Stimulator, Photic, Evoked Response).
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