BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Optina-4C (MHRC-C1N)

    K Number: K250770 · Decision Sep 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    2
    Review Days
    175

    Basic Information

    Device Name
    Optina-4C (MHRC-C1N)
    K Number
    K250770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optina Diagnostics, Inc.
    Date Received
    March 13, 2025
    Decision Date
    September 4, 2025
    Product Code
    HKI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HKI Camera, Ophthalmic, Ac-Powered

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    Other Clearances by Optina Diagnostics, Inc.

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    K231230 Optina-4C (MHRC-C1N)