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510(k) Data Aggregation

    K Number
    K033655
    Device Name
    SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
    Date Cleared
    2004-07-30

    (252 days)

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

    SOFLEX CONTACT LENS INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Keratoconia management and for the correction of myopia and hyperopia in aphakic and nonaphakic persons that may exhibit refractive and/or corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with irregular astigmatism and may be disinfected with a chemical or heat disinfection system. The Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Keratoconia management and for the correction of myopia, hyperopia and astigmatism in aphakic and non-aphakic persons that exhibit refractive and/or post-refractive surgery corneal irregularity corneal astigmatism. The lens may be disinfected with a chemical or heat disinfection system.
    Device Description
    Not Found
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    K Number
    K030842
    Device Name
    ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP
    Date Cleared
    2003-06-06

    (81 days)

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

    SOFLEX CONTACT LENS INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system. The Eni-Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system. The Eni-Eve Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of astigmatism in persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lenses may be disinfected using a chemical disinfection system.
    Device Description
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    K Number
    K020642
    Device Name
    SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
    Date Cleared
    2002-05-24

    (86 days)

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

    SOFLEX CONTACT LENS INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Soft K. (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system. The Soft K. Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.
    Device Description
    Not Found
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    K Number
    K013467
    Device Name
    TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
    Date Cleared
    2001-11-20

    (33 days)

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

    SOFLEX CONTACT LENS INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Toric Eye-Q (Xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 5.00 diopters. The lens may be disinfected using a chemical disinfection system.
    Device Description
    Toric Eye-Q (xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear
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    K Number
    K013469
    Device Name
    EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
    Date Cleared
    2001-11-20

    (33 days)

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

    SOFLEX CONTACT LENS INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Eye-Q (Xylofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected using a chemical disinfection system.
    Device Description
    Soflex Eye-Q (Xylofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear
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    K Number
    K011256
    Device Name
    TORIC LITE LENS
    Date Cleared
    2001-07-17

    (84 days)

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

    SOFLEX CONTACT LENS INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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