BEUDAMED
    Product Code: HMK FDA class 2 21 CFR 886.1250

    Euthyscope, Ac-Powered

    Ophthalmic

    The AC-Powered Euthyscope is an electrically powered ophthalmic device that projects a bright light with a central disc occluder onto the retina, used in the diagnosis and treatment of eccentric fixation associated with amblyopia, helping to determine the location of the preferred retinal locus. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is HMK, regulated under 21 CFR 886.1250, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HMK
    Device Class
    FDA class 2
    Regulation Number
    886.1250
    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 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.