BEUDAMED
    Product Code: HPI FDA class 1 21 CFR 886.5915

    Aid, Vision, Optical, Ac-Powered

    Ophthalmic

    An AC-Powered Optical Vision Aid is a mains-powered ophthalmic device that uses optical magnification systems to assist individuals with low vision in reading and performing close visual tasks, typically by projecting a magnified image onto a display surface or using fixed optical components. This device is FDA Class 1 (lowest risk), subject to general controls without requiring premarket notification. It carries product code HPI and is regulated under 21 CFR 886.5915, within the Ophthalmic medical specialty.

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    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HPI
    Device Class
    FDA class 1
    Regulation Number
    886.5915
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.