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510(k) Data Aggregation

    K Number
    K090806
    Device Name
    SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
    Manufacturer
    SAFILENS, S.R.L.
    Date Cleared
    2009-12-18

    (268 days)

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

    SAFILENS, S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safi-gel Daily Disposable (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes. The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
    Device Description
    The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA), crosslinked with ethylene glycol dimethacrylate (45%). The hydrated lens contains 55% water by weight with a hyaluropolymer. The lens is tinted using a UV absorbing compound (RUVA-93) incorporated into the polymer and Pigment Blue 15 (copper phthalocyanine). The lens acts as a refracting lens to focus light rays on the retina. The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens is available as a single vision lens, which incorporates a bi-curve reduced optic front surface. The peripheral curve is tangential at the back optic zone. The Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens design incorporates a cylinder and base curve, and a bi-curve reduced optic front surface. The peripheral curve is tangential at the back surface. This makes both sides thicker at the upper and lower half of the front surface to keep the axis stable. The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens. The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions: Diameter: 14.2 mm Center Thickness: 0.08 mm (-3.00D) dry Base Curves: 8.70 mm and 8.30 mm Powers: +4.00D to -6.00D (in 0.25D steps), +4.50D to +12.00D (in 0.50D steps), -6.50D to -20.00D (in 0.50D steps) The Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions: Diameter: 14.5 mm Center Thickness: 0.08 mm (-3.00D) dry Base Curves: 8.70 mm Powers: +4.00D to -6.00D (in 0.25D steps), +4.50D to +12.00D (in 0.50D steps), -6.50D to -20.00D (in 0.50D steps) Cylinder Power: -0.50DC to -2.50D Axis: Full circle (in 10°steps) The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera of the following dimensions: Diameter: 14.0mm to 15.0mm Center Thickness: 0.06mm to 0.40mm Base Curve: 8.40mm to 9.30mm Powers: +12.00 Diopters to -20.00 Diopters Add Powers: Continuous add power to +3.25 Zone Sizes: 1.5, 1.9 mm The physical/optical properties of the lens are: Refractive Index: 1.410 (wet) Light Transmittance: 90.3% UV Transmittance: 9.3% Water Content: 55%
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