BEUDAMED
    Product Code: HJD FDA class 1 21 CFR 886.1160

    Illuminator, Color Vision Plate

    Ophthalmic

    The Color Vision Plate Illuminator is an ophthalmic accessory that provides standardized, controlled illumination for pseudoisochromatic color vision test plates, ensuring consistent test conditions when evaluating color vision deficiencies. It is classified as FDA Class 1, representing the lowest risk category, requiring only general controls without a premarket notification submission. The product code is HJD, regulated under 21 CFR 886.1160, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HJD
    Device Class
    FDA class 1
    Regulation Number
    886.1160
    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
    K873913 COLOR BOOK ILLUMINATOR STAND

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.