FDA Registration
Inactive
🇺🇸 United States
Optain Resolve Fundus Camera
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OPTAIN HEALTH
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 526 S Main St Ste 211
- City
- Akron
- State
- OH
- ZIP
- 44311
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250683
Owner / Operator
- Firm Name
- Optain Health
- Operator Number
- 10093665
- Address
- 526 S Main St, Suite 211
- City
- Akron
- State
- OH
- Postal Code
- 44311
- Country
- US
- Correspondent
- Emilia Gonzalez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2025-06-19 |
Proprietary Names
Optain Resolve Fundus Camera
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility