Data / Medical devices / United States / Eyenuk
Eyenuk: FDA-registered device maker in Woodland Hills, CA, United States, 2 510(k) clearances
Eyenuk is registered with the FDA (registration 3013924858) in Woodland Hills, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013924858
- Address
- 5850 Canoga Ave Ste 400, Woodland Hills, CA, United States, 91367
- Owner or operator
- Eyenuk (10077823)
- Roles
- Manufacturer
- First device listed
- October 2, 2020
- Registered through
- 2026
- Brand names listed
- EyeArt
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diabetic Retinopathy Detection Device | PIB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2023 | K223357 | EyeArt v2.2.0 | PIB | Substantially Equivalent | Eyenuk, Inc. | accessdata.fda.gov |
| August 3, 2020 | K200667 | EyeArt | PIB | Substantially Equivalent | Eyenuk, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.