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510(k) Data Aggregation

    K Number
    K220045
    Device Name
    TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
    Date Cleared
    2022-08-05

    (212 days)

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

    DK Medivision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 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 eye care professionals may prescribe the lens for single use daily disposable or daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.
    Device Description
    The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN). The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are available clear, tinted for visibility, or tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Iron Oxide, C.I. Reactive Blue No.4, Reactive Black 5, Titanium Dioxide. When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm. The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315mm), and >50% in the UVA range (316nm - 380nm). The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured in an aspheric design configuration.
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