BEUDAMED
    Product Code: ODK

    Refractive Corneal Implant

    Unknown

    The Refractive Corneal Implant (product code ODK) is an ophthalmic implant intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus, with the goal of restoring functional vision and potentially deferring the need for corneal transplantation. The device is surgically implanted within the cornea to alter its refractive properties. It has a device class of "f," indicating marketing authorization through a humanitarian device exemption (HDE) or similar pathway, and carries an implant flag; it has no assigned regulation number or medical specialty code.

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

    Product Code
    ODK
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    6

    Device Characteristics

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

    Definition

    Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred.