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510(k) Data Aggregation

    K Number
    K142275
    Device Name
    Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
    Manufacturer
    NEO VISION CO., LTD.
    Date Cleared
    2014-10-07

    (53 days)

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

    NEO VISION CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism 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 eye. Eye care practitioners may prescribe the lens frequent repacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.
    Device Description
    Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is available as a single vision lens. The lens material, polymacon is hydrophilic polymer of 2-hydroximethyl methacrylate (HEMA) cross-linked with ethyleneglycol dimethacrylate(62%) and water(38%). Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is colored with one or a combination of one or more of the following color additives: Titanium dioxide (white), C.I Pigment blue 36, Iron oxides, C.I. Pigment green 7, C.I. Pigment violet 23, D&C Yellow No.10. Neo Vision Neo Cosmo is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera with the following dimensions: - Diameter: 13.8mm to 14.5mm - Base Curve: 8.0mm to 9.0mm - Center Thickness: 0.05mm to 0.135 (varies with power) - Powers: 0.00D to -10.00D
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