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

    SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

    K Number: K061157 · Decision Jun 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    24
    Applicant Total
    10
    Review Days
    57

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    Basic Information

    Device Name
    SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
    K Number
    K061157
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bausch & Lomb
    Date Received
    April 26, 2006
    Decision Date
    June 22, 2006
    Product Code
    MVN
    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
    MVN Lens, Contact, (Disposable)

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    Other Clearances by Bausch & Lomb

    K Number Device Name
    K133486 STELLARIS PC VISION ENHANCEMENT SYSTEM
    K133242 STELLARIS VISION ENHANCEMENT SYSTEM
    K131958 BAUSCH & LOMB INJECTOR SYSTEM
    K133146 BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
    K132481 EASY-LOAD LENS DELIVERY SYSTEM
    K132593 CRYSTALSERT DELIVERY SYSTEM
    K123736 CRYSTALSERT DELIVERY SYSTEM
    K040913 NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
    K020927 BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS