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510(k) Data Aggregation

    K Number
    K131783
    Device Name
    POLAROID CONTACTSPOD
    Manufacturer
    Date Cleared
    2014-02-21

    (249 days)

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

    VIOPTI LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Contactspod is a sterile single-use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. It is not a replacement for your normal contact lens rub and rinse cleaning and disinfecting care regime. It is a clear solution and should not be used, if cloudy or discoloured. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
    Device Description
    The Contactspod is a sterile single use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. The Contactspod comprises an injection mouided medical grade polypropylene case and medical grade TPE basket seal. The contactspod is pre filled with 5ml of multi-purpose solution. The MPS solution is supplied inside the moulded PP case with an aluminium / PE heatseal which is removed by the user. Once lenses are inserted into the solution a secondary seal is used to seal the case.
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