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510(k) Data Aggregation

    K Number
    K021907
    Device Name
    IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    IGEL VISION CARE PTE LTD.
    Date Cleared
    2002-09-04

    (86 days)

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

    IGEL VISION CARE PTE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K020855
    Device Name
    IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT
    Manufacturer
    IGEL VISION CARE PTE LTD.
    Date Cleared
    2002-06-04

    (81 days)

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

    IGEL VISION CARE PTE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the corrective ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The Iqel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters. The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
    Device Description
    The Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.
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    K Number
    K984523
    Device Name
    IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
    Manufacturer
    IGEL VISION CARE PTE LTD.
    Date Cleared
    1999-02-16

    (57 days)

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

    IGEL VISION CARE PTE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.
    Device Description
    The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power : -0.50D to -8.00D (in 0.25D steps); -8.50D to -12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps). The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.
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    K Number
    K974837
    Device Name
    IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
    Manufacturer
    IGEL VISION CARE PTE LTD.
    Date Cleared
    1998-07-06

    (194 days)

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

    IGEL VISION CARE PTE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Igel®56 (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.
    Device Description
    The Igel® 56 (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: 14 - 2mm Chord diameter: Center thickness: Sphere: 0.09mm (at-3.00 D) variable optic zone Optic Zone: with power Base Curve: 8.60mm -0.50D to -8.00D (in Power : 0.25D steps): -8.50D -12.00D (in to 0.50D steps); +0.50D to +6.00D (in 0.25D steps) Chord diameter: 14 - 6mm Toric: 0.15mm Center thickness: 8.45mm Optic Zone: 8.70mm Base Curve: Sphere: Plano to -8.00 D (in 0.25 D steps) Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cvlinder: 80, 90, 100, 160, 170, 180, 10 Axis: & 20° The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-vinyl pyrrolidinone. The blue tinted lens also contains D&C Green #6. The apparent color of the visibility tint may decrease slowly following repeated disinfection, but this will not affect the safety or performance of the lenses. When fully hydrated, the lens is 56% water by weight.
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