BEUDAMED
    Product Code: HJY FDA class 1 21 CFR 886.5800

    Reader, Bar, Ophthalmic

    Ophthalmic

    The Ophthalmic Bar Reader is a low-vision device consisting of an optical bar, typically a cylindrical lens or prismatic element, placed over text to provide line-by-line magnification, assisting patients with reduced central vision to read printed material. It is classified as FDA Class 1, representing the lowest risk category, subject only to general controls with no premarket submission required. The product code is HJY, regulated under 21 CFR 886.5800, 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
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HJY
    Device Class
    FDA class 1
    Regulation Number
    886.5800
    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
    K781459 MONOJECT SCALE MAGNIFIER

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.