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

    BENZ-G 4X HIOXIFILCON D

    K Number: K062854 · Decision Aug 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    12
    Review Days
    315

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    Basic Information

    Device Name
    BENZ-G 4X HIOXIFILCON D
    K Number
    K062854
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Benz Research and Development Corp.
    Date Received
    September 25, 2006
    Decision Date
    August 6, 2007
    Product Code
    LPL
    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
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by Benz Research and Development Corp.

    K Number Device Name
    K101122 BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
    K003861 BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)
    K992692 EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
    K983773 BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
    K980418 BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER
    K972807 (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI
    K963744 BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)
    K963512 BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
    K964528 (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT
    K961103 BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
    Search all 12 clearances from Benz Research and Development Corp. →