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

    MONARCH III IOL DELIVERY SYSTEM

    K Number: K063155 · Decision Mar 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    38
    Applicant Total
    6
    Review Days
    161

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    Basic Information

    Device Name
    MONARCH III IOL DELIVERY SYSTEM
    K Number
    K063155
    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
    October 17, 2006
    Decision Date
    March 27, 2007
    Product Code
    KYB
    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
    KYB Lens, Guide, Intraocular

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    Other Clearances by Alcon Manufacturing, Ltd.

    K Number Device Name
    K120912 INFINITI(R) VISION SYSTEM
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    K101774 MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
    K101285 CONSTELLATION VISION SYSTEM
    K093210 AQUALASE CAPSULE WASH TIP