BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)

    K Number: K101774 · Decision Oct 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    476

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    Basic Information

    Device Name
    MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
    K Number
    K101774
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Manufacturing, Ltd.
    Date Received
    June 24, 2010
    Decision Date
    October 13, 2011
    Product Code
    MSS
    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
    MSS Folders And Injectors, Intraocular Lens (Iol)

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    Other Clearances by Alcon Manufacturing, Ltd.

    K Number Device Name
    K120912 INFINITI(R) VISION SYSTEM
    K112425 INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
    K101285 CONSTELLATION VISION SYSTEM
    K093210 AQUALASE CAPSULE WASH TIP
    K063155 MONARCH III IOL DELIVERY SYSTEM