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510(k) Data Aggregation

    K Number
    K223397
    Device Name
    HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
    Manufacturer
    Date Cleared
    2024-01-03

    (421 days)

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

    HOYA Lamphun Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HOY A Illumina (sorafilcon A) Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -12.00D, exhibiting astigmatism of 1.00 diopter or less that does not interfere with visual acuity. The HOY A Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D. The lenses may be worm by persons who exhibit astigmatism of up to 2.75 diopters that does not interfere with visual acuity. The HOY A Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in non-aphakic person with non-diseased eyes in spherical powers ranging from +5.00D to -10.00D with add power ranging from +0.50D to +2.50D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity. The sorafilcon A contact lenses are to be prescribed for single-use disposable wear and are to be discarded upon each removal.
    Device Description
    The HOY A sorafilcon A material is made from a hydrophilic siloxane copolymer of N-vinyl pyrrolidone and is 48% water by weight when immersed in a sterile phosphate buffered saline packaging solution. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280 nm to 315 nm and less than 50% in the UVA range of 316 nm to 380 nm. The HOYA sorafilcon A Contact Lens is to be prescribed for single-use disposable wear. The physical properties of the lens are: Refractive Index: 1.408 Light Transmittance: ≥ 95% Water Content: 48% Specific Gravity: 1.123 Surface Character: Hydrophilic Oxygen Permeability: 112 x 10-11 (cm²/sec)(cm³O₂)/(mL x mmHg) @ 35 °C (polarographic method). The lenses will be manufactured with the following parameters: Diameter: 14.0 mm to 14.7 mm Center Thickness: 0.062 mm to 0.330 mm Base Curve: 8.40 mm to 9.20 mm Power Range: +5.00D to -12.00D Cylinder Power (Toric): -0.75D to -2.75D Cylinder Axis: 0 o to 180 o in 10 o increments Add Power Range: +0.50D to +2.50D
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