BEUDAMED
    Product Code: HOM FDA class 1 21 CFR 886.1810

    Screen, Tangent, Ac-Powered (Campimeter)

    Ophthalmic

    An AC-Powered Tangent Screen Campimeter is an electrically powered ophthalmic diagnostic device that automates target presentation for central visual field testing, providing systematic mapping of visual field defects with consistent and reproducible stimulus delivery. This device is FDA Class 1 (lowest risk), subject to general controls only without premarket notification. It carries product code HOM and is regulated under 21 CFR 886.1810, within the Ophthalmic medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HOM
    Device Class
    FDA class 1
    Regulation Number
    886.1810
    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
    K860642 PHOTRON VISUAL FIELD ANALYZER