BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS

    K Number: K012852 · Decision Mar 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    214

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    Basic Information

    Device Name
    EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
    K Number
    K012852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3920
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optonol, Ltd.
    Date Received
    August 24, 2001
    Decision Date
    March 26, 2002
    Product Code
    KYF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KYF Implant, Eye Valve

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