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

    iStent infinite Trabecular Micro-Bypass System, Model iS3

    K Number: K220032 · Decision Aug 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    209

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    Basic Information

    Device Name
    iStent infinite Trabecular Micro-Bypass System, Model iS3
    K Number
    K220032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3920
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glaukos Corporation
    Date Received
    January 5, 2022
    Decision Date
    August 2, 2022
    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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