BEUDAMED
    Product Code: HPE FDA class 1 21 CFR 886.5915

    Aid, Vision, Optical, Battery-Powered

    Ophthalmic

    A Battery-Powered Optical Vision Aid is a portable ophthalmic device that uses optical magnification components powered by a battery to assist individuals with low vision in performing visual tasks such as reading and identifying objects at near or intermediate distances. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HPE and is regulated under 21 CFR 886.5915, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

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    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HPE
    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
    —
    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
    K884540 ETV, ELECTRONIC VISION AID

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.