BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTAIN HEALTH

    Reg #: 3038790635 · FEI: 3038790635 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    OPTAIN HEALTH
    Registration Number
    3038790635
    FEI Number
    3038790635
    Status
    Active
    Expiry Year
    2026
    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
    Camera, Ophthalmic, Ac-Powered HKI

    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