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510(k) Data Aggregation

    K Number
    K130931
    Device Name
    EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
    Date Cleared
    2013-08-30

    (148 days)

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

    JIANGSU HORIEN CONTACT LENS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EASY DAY (methafilcon A) 1-Day Soft ( Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.75 diopters that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0 ~ - 12.00D. The lens is indicated for single use daily disposable wear and patients are instructed to discard the lens after each removal.
    Device Description
    EASY DAY (methafilcon A) 1-Day Soft (hydrophilic) contact lens is available as a single vision aspherical lens. The lens material, methafilcon A is a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) cross-linked with ethylene glycol dimethacrylate (EGDMA) . The lens with visible tint is tinted blue using reactive blue 4K to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing buffered saline solution.
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