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510(k) Data Aggregation

    K Number
    K000133
    Device Name
    MENICON Z
    Manufacturer
    MENICON U.S.A., INC.
    Date Cleared
    2000-05-19

    (122 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972443
    Device Name
    MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    MENICON U.S.A., INC.
    Date Cleared
    1997-08-22

    (53 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENICON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Menicon SF-P (melafocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only. The Menicon Z (tisilfocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
    Device Description
    The Menicon SF-P (melafocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate, siloxanylmethacrylate and methacrylic acid with water absorbance of less than 0.5% by weight. The lens is available in blue tint. The blue tinted lens contains D&C Green No. 6 as the color additive. The Menicon Z (tisilfocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. Lens colors available are light blue and violet. The blue lens is tinted with color additive D & C Green No. 6 and the violet lens contains the color additives D & C Green No. 6 and D & C Violet No. 2. Also, UV absorber is added. Solution used for packaging the Menicon RGP lenses: BARNES-HIND® ComfortCare® GP WETTING & SOAKING SOLUTION, which contains edetate disodium and chlorhexidine gluconate as preservatives.
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    K Number
    K970019
    Device Name
    MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
    Manufacturer
    MENICON U.S.A., INC.
    Date Cleared
    1997-03-25

    (82 days)

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

    MENICON U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.
    Device Description
    The alternate designs of the Menicon Z (tisilfocon A) contact lens are bifocal and trifocal design contact lenses. Conventional bifocal / trifocal designs are employed in the alternate designs of Menicon Z (tisilfocon A) rigid gas permeable contact lenses. The lens material, tisilfocon A, is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is classified fluoro-silicone acrylate, group III, page 16, FDA's premarket notification (510(k)) guidance document for daily wear contact lenses. May 12. 1994. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (2-(5-Chloro-2Hbenzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol)) is added.
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