BEUDAMED
    Product Code: OGO FDA class 3

    Intraocular Pressure Lowering Implant

    Unknown

    The Intraocular Pressure Lowering Implant is a surgically implanted device intended to reduce intraocular pressure in eyes that have not responded to conventional medical and surgical treatment, typically used in refractory glaucoma. It is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA) due to the significant risk associated with an implanted device in the eye that supports critical physiological functions. The product code is OGO, reviewed by the Ophthalmic panel; no specific regulation number has been assigned. It carries an implant flag indicating permanent or semi-permanent placement within the body.

    View on FDA
    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OGO
    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

    Definition

    An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.