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510(k) Data Aggregation

    K Number
    K974408
    Device Name
    PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
    Manufacturer
    BIOCOMPATIBLES EYEWEAR, INC.
    Date Cleared
    1998-04-16

    (143 days)

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

    BIOCOMPATIBLES EYEWEAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Proclear and Proclear Compatibles (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only). Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement.
    Device Description
    The Proclear and Proclear Compatibles contact lenses are available as a lathe cut spherical lens, and a molded spherical lens. The lens material (omafilcon A) is a copolymer of 2-hydroxyethy)methacrylate and 2methactyloyloxyethyl phosphorylcholine crosslinked with ethylenestycol dimethacrylate. The Proclear lens with visibility tint is timed blue using Reactive Blue Dye #4 to make the lens more visible for handling.
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    K Number
    K980218
    Device Name
    METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    BIOCOMPATIBLES EYEWEAR, INC.
    Date Cleared
    1998-03-23

    (66 days)

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

    BIOCOMPATIBLES EYEWEAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LL-55 (methafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
    Device Description
    The LL-55 contact lenses are available as lathe cut spherical lens. The lens material (methafilcon A) is a hydrophilic polymer of hydroxyethylmethacrylate and methacrylic acid.
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    K Number
    K970095
    Device Name
    PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
    Manufacturer
    BIOCOMPATIBLES EYEWEAR, INC.
    Date Cleared
    1997-04-03

    (83 days)

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

    BIOCOMPATIBLES EYEWEAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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