BEUDAMED
    Product Code: NCK FDA class 1 21 CFR 886.3200

    Button, Iris, Eye, Artificial

    Ophthalmic

    The Artificial Iris Button (Eye) is an ophthalmic prosthetic device designed to cosmetically restore the appearance of the iris in patients with iris defects or absence due to trauma, surgery, or congenital conditions. It is placed on or near the corneal surface. Classified as FDA Class 1, it is subject to general controls under regulation 886.3200 (Ophthalmic specialty).

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

    Basic Information

    Product Code
    NCK
    Device Class
    FDA class 1
    Regulation Number
    886.3200
    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
    K001326 NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

    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.