BEUDAMED
    Product Code: HMJ FDA class 1 21 CFR 886.1810

    Screen, Tangent, Projection, Battery-Powered

    Ophthalmic

    The Battery-Powered Projection Tangent Screen is a portable ophthalmic device used in visual field testing that projects illuminated targets onto a flat, calibrated screen to allow mapping of central visual field defects and peripheral boundaries. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HMJ, regulated under 21 CFR 886.1810, 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
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    1

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    Basic Information

    Product Code
    HMJ
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K934084 BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
    K924753 BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE