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510(k) Data Aggregation

    K Number
    K032481
    Device Name
    THERATEARS CONTACT LENS COMFORT DROPS
    Date Cleared
    2003-11-04

    (84 days)

    Product Code
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VISION RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TheraTears Contact Lens Comfort Drops is indicated - to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact lenses. - to help relieve dryness, discomfort and irritation that may be associated with lens wear and, - to cushion lenses and ease insertion. * RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.
    Device Description
    TheraTears® brand Contact Lens Comfort Drops contains carmellose sodium in purified water as a lubricant. It is a sterile, hypotonic, borate buffered solution containing the following essential electrolytes found in natural tears: sodium chloride, potassium chloride, sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride, and sodium phosphate. The gentle patented preservative system consists of sodium perborate stabilized with phosphonic acid. This solution contains no chlorhexidine, no thimerosal and no other mercury-containing ingredients, and it contains no detergents.
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