Neolight PCI 40-1004
by Neolight LLC
Neolight PCI 40-1004 is an ophthalmic fundus camera (FDA Class II; FDA product code HKI, Camera, Ophthalmic, Ac-Powered) made by Neolight LLC, cleared under FDA 510(k) K223575 on 6 Sep 2023 and listed in FDA GUDID since 26 Jan 2025 (UDI-DI 00852788008026), 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 | Number00852788008026 | Date26 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223575 | Date6 Sep 2023 | StatusActive |
Official records
- AccessGUDID record 00852788008026
- FDA 510(k) database K223575
Across registries
- FDA 510(k) K223575 decided 6 Sep 2023 Active
- FDA GUDID UDI-DI 00852788008026 listed 26 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K223575
- Listed FDA GUDID 00852788008026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Neolight
- Generic name
- Ophthalmic fundus camera
- Model / reference
- PCI 40-1004
- Primary DI / UDI-DI
- 00852788008026
- 510(k) Number
- FDA product code
- HKI
- GMDN term
- Ophthalmic fundus camera
- Device class
- Class II
- Regulation number
- 886.1120
- GUDID distribution status
- In Commercial Distribution
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