BEUDAMED
    Product Code: HPF FDA class 1 21 CFR 886.5900

    Aid, Vision, Electronic, Ac-Powered

    Ophthalmic

    An AC-Powered Electronic Vision Aid is a mains-powered device that uses electronic image capture and display technology to magnify and enhance visual content for individuals with low vision, enabling them to read, view images, and perform daily visual tasks more effectively. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HPF and is regulated under 21 CFR 886.5900, within the Ophthalmic medical specialty.

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

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    Basic Information

    Product Code
    HPF
    Device Class
    FDA class 1
    Regulation Number
    886.5900
    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
    K863993 VTS REPORTER OR VTS LINK

    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.