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510(k) Data Aggregation

    K Number
    K122220
    Device Name
    ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
    Manufacturer
    SOFLEX LIMITED
    Date Cleared
    2013-03-19

    (237 days)

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

    SOFLEX LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eni-Eye SH Soft K Semi Scleral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system. Eni-Eye SH Soft K Toric Semi Scleral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 5.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system.
    Device Description
    Not Found
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    K Number
    K122213
    Device Name
    ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    SOFLEX LIMITED
    Date Cleared
    2012-12-12

    (140 days)

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

    SOFLEX LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons.
    Device Description
    Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
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    K Number
    K110261
    Device Name
    ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
    Manufacturer
    SOFLEX LIMITED
    Date Cleared
    2011-07-28

    (181 days)

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

    SOFLEX LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lens may be disinfected using a chemical disinfection system. The Eni-Eye Q SH Multi (Efrofilcon 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-Eye Q SH Multi Toric (Efrofilcon 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 SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea 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 non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system. The Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea 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 non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00DS that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
    Device Description
    Not Found
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