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

    Molteno3 Glaucoma Implant

    K Number: K152996 · Decision Dec 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    65

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    Basic Information

    Device Name
    Molteno3 Glaucoma Implant
    K Number
    K152996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3920
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Ophthalmic Products, Inc. (Iop)
    Date Received
    October 13, 2015
    Decision Date
    December 17, 2015
    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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