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510(k) Data Aggregation

    K Number
    K991995
    Device Name
    SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
    Manufacturer
    Date Cleared
    1999-08-27

    (74 days)

    Product Code
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    MZD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SOFTCHROME TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect iris color. Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.
    Device Description
    SOFTCHROME TINTS Transparent Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. The lenses are tinted with utilization of the patented "In-Office Tinting System for Soft Contact Lenses". The tinting system consists of various tinting fixtures, calibrated mixing vessels, pre-mixed color additives, activator solution, neutralizer solution, tinting instructions, tips and recipes. The lens tinting process uses color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The In-Office Tinting System for Soft Contact Lenses offers a variety of colors and intensity levels. The SOFTCHROME TINTS Transparent Tinted Soft Contact Lens is also available in a variety of colors for visibility-handling tint. The color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 86. or reactive orange 78. The color additives used are not removed by lens handling and approved 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.
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