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510(k) Data Aggregation

    K Number
    K983637
    Device Name
    ACTIFRESH 400 LENS
    Manufacturer
    HYDRON LTD.
    Date Cleared
    1999-12-10

    (420 days)

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

    HYDRON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hydron ActiFresh 400 (lidofilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. Eyecare practitioners may prescribe the lens for frequent replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
    Device Description
    The ActiFresh 400 soft contact lens is a hemispherical shell manufactured of a high water content (73%), polymerised material of n-vinyl pyrrolidone (nVP) and methy methacrylate (MMA) and other components which yield the appearance of a lens which is designed to fit over the corneal surface of the eye. A UV filter has been incorporated into the lens material. The lens is visibility tinted with a minute amount of poly (2-hydroxyethyl methacrylate and Reactive Blue Dye #4 copolymer. The lens is designed with varying base curves which conform to the shape of the radius of the cornea and centre over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness) and hyperopia (farsightedness). The lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. The lens is designed with a spherical lenticulated front surface and spherical bicurve back surface. The lens is manufactured by cast molding.
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    K Number
    K983160
    Device Name
    ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
    Manufacturer
    HYDRON LTD.
    Date Cleared
    1999-02-18

    (162 days)

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

    HYDRON LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hydron ActiToric(ocufilcon A) Soft (Hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters. Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
    Device Description
    The ActiToric soft contact lens is a hemispherical shell manufactured of polymerised material of HEMA and other monomeric incredients crosslinked with EGDMA and other components which yield the appearance of a lens which is designed to fit over the corneal surface of the eve. This lens is designed with varying base curves which conform to the shape of the radius of the cornea and centre over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (near-sightedness), hyperopia (farsightedness) and astigmatism (multiple foci). The lens provides corrective power which is to correspond to the refractive power of the eve to which it is being treated. The lens has an aspheric base curve that is formed in the free surface during the spinning process. Secondary and tertiary curves as well as bevelled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mould to provide consistent optics. Onentation marks are moulded into the front surface as part of the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort. Axis stabilisation is action of the action of the lids on the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.
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