Data / Medical devices / United States / Optain Health
Optain Health: FDA-registered device maker in Akron, OH, United States, 1 510(k) clearance
Optain Health is registered with the FDA (registration 3038790635) in Akron, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038790635
- Address
- 526 S Main St Ste 211, Akron, OH, United States, 44311
- Owner or operator
- Optain Health (10093665)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 19, 2025
- Registered through
- 2026
- Brand names listed
- Optain Resolve Fundus Camera
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 30, 2025 | K250683 | Resolve Fundus Camera | HKI | Substantially Equivalent | Optain Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 30, 2025. 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.