BEUDAMED
    Product Code: HPD FDA class 1 21 CFR 886.1375

    Lens, Bagolini

    Ophthalmic

    A Bagolini Lens is a diagnostic ophthalmic lens containing fine striations that scatter light into a line, used in orthoptic and binocular vision assessment to evaluate fixation, fusion, anomalous retinal correspondence, and suppression in patients with strabismus. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HPD and is regulated under 21 CFR 886.1375, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

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    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HPD
    Device Class
    FDA class 1
    Regulation Number
    886.1375
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✓
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.