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

    BAUSCH + LUMB, VIS100 INJECTOR SYSTEM

    K Number: K133146 · Decision Jan 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    10
    Review Days
    78

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    Basic Information

    Device Name
    BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
    K Number
    K133146
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bausch & Lomb
    Date Received
    October 17, 2013
    Decision Date
    January 3, 2014
    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 Bausch & Lomb

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    K132481 EASY-LOAD LENS DELIVERY SYSTEM
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    K061157 SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
    K040913 NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
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