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510(k) Data Aggregation

    K Number
    K141280
    Device Name
    ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
    Date Cleared
    2014-07-18

    (63 days)

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

    SEINOH OPTICAL CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iLens® (ocufileon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.00D to +20.00D. The lens may be wom by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care prescribe the lens for either single-use disposable wear or for frequent replacement wear. When prescribed for frequent replacement wear, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. As prescribed for single use daily dispossble wear, patients are instructed to dispose of the lens at each removal. The iLens® Daily Wear Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
    Device Description
    The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is a . spherical lens with UV blocker. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is . available in hemispherical shell. The lenses are made of HEMA hydrogel. The composition is 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.
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