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510(k) Data Aggregation

    K Number
    K171163
    Device Name
    Contact Lens Case Round Glasses
    Manufacturer
    FiftyTwoWays Ltd
    Date Cleared
    2017-06-27

    (68 days)

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

    FiftyTwoWays Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONTACT LENS CASE ROUND GLASSES is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
    Device Description
    The Contact Lens Case Round Glasses is leak-proof and made from durable plastic with secure, snap lids. Note: can be used with hard and soft contact lenses; for chemical disinfection only; rinse case thoroughly before initial use; replace contact case every 2 months. The secure snap lids are connected to the body by stainless steel hinges and securely close by use of the silicon seal within the plastic Each compartment has a capacity of 4,4ml and diameter of 26,5mm and an overall dimension of 76mm x 29mm x 17mm The Case body is in White Color and the Lids in Black Color with transparent windows. Contact lenses can be fully immersed in each compartment, and each compartment fit all standard lenses currently being sold in the market. The side of each compartment is marked with L (left) or R (right)
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