BEUDAMED
    Product Code: HJQ FDA class 1 21 CFR 886.1870

    Stereoscope, Ac-Powered

    Ophthalmic

    The AC-Powered Ophthalmic Stereoscope is a device used in ophthalmic diagnosis and vision therapy that presents separate images to each eye to assess binocular vision, stereopsis, and ocular alignment. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification. The product code is HJQ, regulated under 21 CFR 886.1870, within the Ophthalmic medical specialty. No special risk flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HJQ
    Device Class
    FDA class 1
    Regulation Number
    886.1870
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K830625 CYTO-STAIN

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.