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510(k) Data Aggregation

    K Number
    K043540
    Device Name
    HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
    Manufacturer
    WESTCON CONTACT LENS CO., INC.
    Date Cleared
    2005-02-01

    (41 days)

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

    WESTCON CONTACT LENS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Horizon 59 Oasis (hioxifilcon A) Spherical, Horizon 59 Oasis (hioxifilcon A) Toric, Horizon 59 Oasis (hioxifilcon A) Bi-con, Horizon 59 Oasis (hioxifilcon A) Bi-con Toric, Horizon 59 Oasis (hioxifilcon A) Progressive, Horizon 59 Oasis (hioxifilcon A) Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes. The color-enhanced version is indicated for daily wear to enhance or alter the apparent eve color. The lenses may be disinfected using chemical systems only.
    Device Description
    The soft contact lenses that are manufactured from Hioxifilcon A lens blanks are lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort. Adding color enhancement to the surface of the lens modifies the clear version of the Horizon 59 Oasis (hioxifilcon A) contact lens. The tinting process alters or changes the lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the irris. The color additives are used in the amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The practitioner may also choose tint intensity and custom mix colors. The Horizon 59 Oasis (hioxifilcon A) lenses are available in shades of the following: blue, green, brown and aqua. Combining one or more reactive colors additives with distilled water forms the color enhancement. The reactive color additives that may be used either alone or in combination are: Reactive Blue 19, Reactive Black 5, Reactive Red 11, Reactive Orange 78, Reactive Yellow 15, Reactive Red 180.
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    K Number
    K031774
    Device Name
    HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
    Manufacturer
    WESTCON CONTACT LENS CO., INC.
    Date Cleared
    2004-02-20

    (256 days)

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

    WESTCON CONTACT LENS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Horizon 55 (methafilcon A), Horizon 55 (methafilcon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes. The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The lenses may be disinfected using chemical systems only. The Horizon 38 (polymacon) (polymacon), Horizon 38 (polymacon) Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism) in aphakic or not-aphakic persons with nondiseased eyes. The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The color-enhanced lenses can be chemically disinfected only. The clear lenses may be disinfected using a heat o chemical disinfecting system.
    Device Description
    The soft contact lenses that are manufactured from W-55 and W-38 lens blanks are lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eves. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort. Adding color enhancement to the surface of the lens modifies the clear version of the Horizon 55 (methafilcon A) Contact Lens and Horizon 38 (polymacon) contact lens. The tinting process alters or changes the lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additives are used in the amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The practitioner may also choose tint intensity and custom mix colors. The Horizon Enhanced lenses are available in shades of the following: blue, green, brown and aqua. Combining one or more reactive colors additives with distilled water forms the color enhancement. The reactive color additives that may be used either alone or in combination are: Reactive Blue 19, Reactive Black 5, Reactive Red 11, Reactive Orange 78, Reactive Yellow 15, Reactive Red 180.
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    K Number
    K023530
    Device Name
    HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
    Manufacturer
    WESTCON CONTACT LENS CO., INC.
    Date Cleared
    2002-11-26

    (36 days)

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

    WESTCON CONTACT LENS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Horizon 38 (polymacon). Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes. The lens may be disinfected using either a heat or chemical system .
    Device Description
    The soft contact lenses that are manufactured from W-38 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of ametropia (myopia, hyperopic and astigmatism). Each lens provides corrective power, which corresponds to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary, as well as, beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.
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    K Number
    K992010
    Device Name
    W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)
    Manufacturer
    WESTCON CONTACT LENS CO., INC.
    Date Cleared
    1999-06-29

    (14 days)

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

    WESTCON CONTACT LENS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Horizon 55 Westint and Horizon 55 (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia.
    Device Description
    W-55 (methafilcon A) clear or tinted lens blanks are a hydrophilic polymer of 2hydroxyethy methacrylate crossed linked with ethyleneglycol dimethacrylate. The lens consists of 45% methafilcon and 55% water by weight when immersed in buffered saline solution. When the lens blank is tinted blue, up to .8 % of the color additive Copper Phthalocyanine Blue Pigment will be added to the MA. The color additive conforms to 21 CFR Part 74.3045. The soft contact lenses that are manufactured from W-55 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (multifocal). Each lens provides corrective power, which corresponds to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.
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    K Number
    K963837
    Device Name
    HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN
    Manufacturer
    WESTCON CONTACT LENS CO., INC.
    Date Cleared
    1996-12-20

    (87 days)

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

    WESTCON CONTACT LENS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962121
    Device Name
    HORIZON/WESTHIN 55-G
    Manufacturer
    WESTCON CONTACT LENS CO., INC.
    Date Cleared
    1996-08-26

    (87 days)

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

    WESTCON CONTACT LENS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954524
    Device Name
    W-55 (METHAFILON A) CONTACT LENS
    Manufacturer
    WESTCON CONTACT LENS CO., INC.
    Date Cleared
    1996-03-28

    (181 days)

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

    WESTCON CONTACT LENS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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