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510(k) Data Aggregation

    K Number
    K101122
    Device Name
    BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    2010-08-09

    (110 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopter or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10 Diopters. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
    Device Description
    The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lenses are hemispherical shells and are available as multifocal lens designs. The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is fabricated from Hioxifilcon D, which is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-, Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linkned with ethylene glycol dimethacrylate (EGDMA). It consists of 46% Hioxifilcon Datod 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, rransparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye.
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    K Number
    K062854
    Device Name
    BENZ-G 4X HIOXIFILCON D
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    2007-08-06

    (315 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Benz-G 4X 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
    Device Description
    Benz-G 4X 54% (hioxifilcon D) lathed soft contact lenses are hemispherical shells and are available as spherical or toric lens designs. The Benz-G 4X 54% (hioxifilcon D) lathed soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifileon D and 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.
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    K Number
    K003861
    Device Name
    BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    2001-03-08

    (85 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992692
    Device Name
    EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1999-10-18

    (68 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 59% extreme H2O® (hioxifilcon A) soft contact lens for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The leas may be worn by persons who exhibit refractive astigmatism of .75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tint. Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When presentbed for frequent/planned replacement wear, the lens may be disinfected using either a heat or chemical disinfection system.
    Device Description
    The 59% extreme H2O® (hioxifilcon A) soft contact lens are hemispherical shells with molded sphencal base curves and molded from surfaces. The 59% extreme H100 soft contact lens are fabricated from (hioxifilcon A) which is a non-ionic ultra high molecular weight copolymer of 2-hydroxyethy) methacy wate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buttered with either sodium bicarbonate or sodium perborate. The lens is available in clear and with a blue visibility handling tint, phthalocyanato (2) - (copper). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The physical properties of the lens are: | PROPERTY | VALUE | |-----------------------------------|-------------------------------------------------------------------------------------| | Refractive Index | 1.515 (dry)<br>1.404 (hydrated) | | Light Transmission: | greater than 95% | | Water Content | 59% | | Specific Gravity | 1.308 (dry)<br>1.136 (hydrated) | | Oxygen Permeability<br>(Dk Value) | 18 X 10-11 Fatt Units<br>(cm²/sec)(ml O₂/ml x mm Hg @<br>35°C), revised Fatt method |
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    K Number
    K983773
    Device Name
    BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1998-12-22

    (57 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BENZ-G 5X SPHERICAL (hioxifilcon A) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and astigmatism of up to 0.75 Diopters where the astigmatism does not interfere with visual acuty. The lens may be disinfected with either a chemical or a heat disinfection system.
    Device Description
    Benz-G 5X (hioxifilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted, lathe-cut)
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    K Number
    K980418
    Device Name
    BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1998-02-27

    (24 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens. The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity. The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction. The lenses may be disinfected using chemical disinfection systems.
    Device Description
    The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens. The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity. The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction. The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve. This non-ionic material is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid crosslinked with Ethylene Glycole Dimethacrylate, plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution. When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.
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    K Number
    K972807
    Device Name
    (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1997-10-15

    (79 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BENZ hefilcon A SPHERICAL Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The spherical lenses are available from +20.00 to -20.00 Diopters and may be worn by patients who can accomodate up to 1.5 Diopters of astigmatism. The BENZ hefilcon A TORIC Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The Toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction where it does not interefere with visual acuity. The BENZ hefilcon A Spherical and Toric Contact lenses may be disinfected using either the heat (thermal) or the chemical (nonheat) disinfection system.
    Device Description
    Not Found
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    K Number
    K963512
    Device Name
    BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1997-07-31

    (335 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963744
    Device Name
    BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1997-07-31

    (317 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964528
    Device Name
    (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT
    Manufacturer
    BENZ RESEARCH AND DEVELOPMENT CORP.
    Date Cleared
    1997-03-07

    (115 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENZ RESEARCH AND DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BENZ-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons who have up to 1.50 Diopters of astigmatism where the astagmatism does not interfare with visual acuity. BENZ-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic The toric lenses are persons with with non-diseased eyes. available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction. The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermall or the chemical (not heat) disinfection system.
    Device Description
    BENZ-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical shell. The non-ionic The Toric has a Toric Base Curve. material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA). The copolymer consists of 52% BENZ-G 3X (hioxifilcon B) and 48% water by weight when immersed in normal saline solution buttered with sodium bicarbonate.
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