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

    U.S. IOL PHACO HANDPIECE

    K Number: K954239 · Decision Dec 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    4
    Review Days
    88

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    Basic Information

    Device Name
    U.S. IOL PHACO HANDPIECE
    K Number
    K954239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U.S. Iol, Inc.
    Date Received
    September 11, 1995
    Decision Date
    December 8, 1995
    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 U.S. Iol, Inc.

    K Number Device Name
    K001768 OCCU-FLO PUNCTUM PLUGS
    K954746 PHACO TIP
    K954240 EVOLUTION PHACOMULSIFIER