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

    CLAREON MONARCH IV IOL Delivery System

    K Number: K212039 · Decision Aug 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    43
    Review Days
    54

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    Basic Information

    Device Name
    CLAREON MONARCH IV IOL Delivery System
    K Number
    K212039
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Laboratories, Inc.
    Date Received
    June 30, 2021
    Decision Date
    August 23, 2021
    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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