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510(k) Data Aggregation

    K Number
    K051477
    Device Name
    MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
    Manufacturer
    MI GWANG CONTACT LENS CO., LTD.
    Date Cleared
    2006-03-10

    (280 days)

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

    MI GWANG CONTACT LENS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiGwang Comfort 38 (polymacon) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The MiGwang Comfort 38 (polymacon) Toric 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/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe any of the above lenses 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 disinfecting system.
    Device Description
    The MiGwang Comfort 38 (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and lathe-cut front surfaces. The MiGwang Comfort 38 soft contact lens is fabricated from a nonionic polymer, The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: C.I. Reactive black 5, C.I. Vat orange 5, Iron oxides, C.I. Pigment green 7, C.I. Vat brown 1, C.I. Vat yellow 3, C.I. Vat blue 6, C.I. vat orange 1, C.I. Vat green 1, C.I. Pigment blue 36, C.I. Pigment violet 23, D&C Green No.6, phthalocyanato (2) copper, D&C Yellow No. 10. D&C Red No. 17 and Titanium dioxide. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back 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. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are: Refractive Index: 1.43 (hydrated) Light Transmission (clear): greater than 90% Light Transmission (tinted): greater than 90% Water Content: 38% ± 2% Oxygen Permeability: 9.77 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
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