Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K123431
    Device Name
    DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
    Manufacturer
    Date Cleared
    2013-06-17

    (222 days)

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

    DREAMCON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dream Color I, II, and III (polymacon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.50 diopters that does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eves. Eyecare practitioners may prescribe 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
    Dream soft contact lenses are hemispherical shape with molded spherical base curves and lathe-cut front surfaces. Its' sectional configuration has symmetrical shape. Back-cover surface except optic zone and edge side is colored with various colors. The lenses are made of hydrophilic polymer of 2-Hydroxyethyl methacrylate(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. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Iron Oxides, C.I. Pigment Green 7, (Phthalocyaninato(2-)) Copper and Reactive Black 5. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only amount of color additive need to accomplish the intended coloring effect. in hydrated state. the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming colored optical surface. The hydrophilic properties of the lens require that it is maintained in a fully hydrated state in a solution compatible with the eye. If the lens dry 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.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1