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

    FLUID ISOLATION DEVICE

    K Number: K091915 · Decision Oct 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    6
    Review Days
    119

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    Basic Information

    Device Name
    FLUID ISOLATION DEVICE
    K Number
    K091915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lenstec, Inc.
    Date Received
    June 30, 2009
    Decision Date
    October 27, 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 Lenstec, Inc.

    K Number Device Name
    K161776 Lenstec LC Injection system
    K122848 LENSTEC LC INJECTION SYSTEM
    K063802 LENSTEC LC INJECTION SYSTEM
    K060533 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
    K050638 LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES