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510(k) Data Aggregation

    K Number
    K991780
    Device Name
    FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C
    Date Cleared
    1999-06-29

    (35 days)

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

    G.T. LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fluorex® 700-UV (flusilfocon A), Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Spherical Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and which may exhibit astiqmatism of 1.50 diopters or less that does not interfere with visual acuity. The Fluorex® 700-UV (flusilfocon A), Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Translating Bifocal and Trifocal Contact Lenses 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 3.50 diopters or less that does not interfere with visual acuity.
    Device Description
    The UV blocking materials contain a UV-absorbing compound incorporated into the fluoro-silicate-acryliccopolymers (flusilfocon A, B, C). The Fluorex® UV (flusilfocon) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.
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    K Number
    K991781
    Device Name
    FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
    Date Cleared
    1999-06-29

    (35 days)

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

    G.T. LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fluorex® Ultra (flusilfocon E) Spherical Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and which may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The Fluorex® Ultra (flusilfocon E) Translating Bifocal and Trifocal Contact Lenses 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 3.50 diopters or less that does not interfere with visual acuity.
    Device Description
    The Fluorex® Ultra (flusilfocon E) is a fluoro-silicate-acrylic-copolymer. The Fluorex® Ultra (flusilfocon E) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.
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