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510(k) Data Aggregation

    K Number
    K133472
    Device Name
    SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
    Date Cleared
    2014-03-04

    (112 days)

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

    SOUFLON PHARMACEUTICALS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopers or less and may exhibit astigmatism up to 1.50 Diopters or less. The SAUFLON CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +4.00 Diopters or less. Sauflon Clariti 1 Day (somolilcon A) Soft (hydrophilic) Daily Disposable Contact lens. with UV blocker and Handling Tim help protect against transmission of harmful UV radiation to the cornea and into the eye.
    Device Description
    The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is available as a single vision, toric, multifocal and multifocal toric lens. The lens muterial (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% somofileon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation. A handling tint is added to the composition of the lens to make the lens visible for handling. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm The Sauflon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent schera, with the following dimensions: Chord Diameter: 13.0mm to 18.0mm Centre Thickness: 0.03mm to 0.70mm Base Curve: 7.5mm to 9.50mm Powers: -30.00 DS to +30.00 DS Toric Cylinder options: -0.75 to -9.75 Toric Axis options: 10° to 180° (5° steps). Multifocal Add: Add power up to +4.00 labelled with indicative add strength to be read in conjunction with the fitting guide. The physical/optical properties of the lenses are: Refractive Index: 1.4008 %Transmittance @ 590nm: 98.30 %Transmittance @ 280-315nm: 0.71 %Transmittance @ 316-380nm: 20.62 Surface Character: Hydrophilic Water Content: 56% Oxygen Permeability (DK): 60 x 10-11 (cm²/sec) (ml O2/ml x mmHg) at 35°C (Fatt Method for determination of oxygen permeability). Specific Gravity: 1.17
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