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510(k) Data Aggregation

    K Number
    K070767
    Device Name
    EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
    Date Cleared
    2007-07-24

    (126 days)

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

    LAPIS LAZULI INTERNATIONAL NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
    Device Description
    The EYE SEE™ Multipurpose Contact Lens Solution is a sterile, isotonic, buffered, solution containing boric acid, sodium chloride, Hydroxypropyl Methylcellulose (HPMC) as a lubricant, poloxamer 407 as a surfactant, disodium edetate as chelating agent, purified water and preserved with polyhexanide. The EYE SEE™ Multipurpose Contact Lens Solution is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
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