BEUDAMED
    Product Code: HJS FDA class 1 21 CFR 886.1910

    Test, Spectacle Dissociation, Ac-Powered (Lancaster)

    Ophthalmic

    The AC-Powered Spectacle Dissociation Test (Lancaster) is an ophthalmic instrument used to assess binocular vision and measure ocular deviations by dissociating the images seen by each eye using polarized or colored filters, enabling mapping of strabismus and motor fusion defects. 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 HJS, regulated under 21 CFR 886.1910, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HJS
    Device Class
    FDA class 1
    Regulation Number
    886.1910
    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 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.