BEUDAMED
    Product Code: NCJ FDA class 3

    Telescope, Implantable, Miniature

    Unknown

    The Implantable Miniature Telescope is a small intraocular telescope surgically implanted in the eye to improve visual acuity in patients with end-stage age-related macular degeneration (AMD), functioning by projecting a magnified image onto healthy peripheral retina around the damaged macula. Classified as FDA Class 3, it requires Premarket Approval (PMA) due to the high risk associated with permanent implantation in the eye. It is reviewed by the Ophthalmic panel and carries the implant flag.

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

    Basic Information

    Product Code
    NCJ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    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.