BEUDAMED
    Product Code: HLS FDA class 1 21 CFR 886.1270

    Exophthalmometer

    Ophthalmic

    The Exophthalmometer is a diagnostic ophthalmic instrument used to measure the degree of forward displacement (proptosis) of the eyeball within the orbit, providing objective quantification of exophthalmos as seen in conditions such as thyroid eye disease. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification requirement. The product code is HLS, regulated under 21 CFR 886.1270, within the Ophthalmic medical specialty. No special risk flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HLS
    Device Class
    FDA class 1
    Regulation Number
    886.1270
    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
    K771900 71110 DESK CHARGER

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.