BEUDAMED
    Product Code: HJX FDA class 1 21 CFR 886.5810

    Reader, Prism, Ophthalmic

    Ophthalmic

    The Ophthalmic Prism Reader is an optical device incorporating prism elements into a reading aid, used to redirect light and allow patients with limited ocular mobility or visual field deficits to read text more comfortably. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification. The product code is HJX, regulated under 21 CFR 886.5810, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

    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
    HJX
    Device Class
    FDA class 1
    Regulation Number
    886.5810
    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
    K000544 BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080

    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.