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

    INFINITI VISION SYSTEM WITH OZIL IP

    K Number: K082845 · Decision Feb 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    16
    Review Days
    139

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    Basic Information

    Device Name
    INFINITI VISION SYSTEM WITH OZIL IP
    K Number
    K082845
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Research, Ltd.
    Date Received
    September 26, 2008
    Decision Date
    February 12, 2009
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Alcon Research, Ltd.

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