BEUDAMED
    Product Code: HLC FDA class 1 21 CFR 886.1460

    Instrument, Measuring, Stereopsis

    Ophthalmic

    The Stereopsis Measuring Instrument is an ophthalmic diagnostic device used to quantify a patient's ability to perceive depth through binocular disparity, providing objective assessment of stereoacuity in conditions such as amblyopia, strabismus, and binocular vision disorders. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without any premarket notification submission. The product code is HLC, regulated under 21 CFR 886.1460, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

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    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HLC
    Device Class
    FDA class 1
    Regulation Number
    886.1460
    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 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.