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510(k) Data Aggregation

    K Number
    K171539
    Device Name
    Contact Lens Case
    Manufacturer
    E-Link Plastic & Metal Industrial Co.,Ltd
    Date Cleared
    2017-07-14

    (49 days)

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

    **E-Link Plastic **& Metal Industrial Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contact Lens Case is a device intended for 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 is medical device for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lids. The case body based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. All the four variant models of this device have a capacity of 5.3 ml to allow contact lenses fully immersed into the well, and the well from these models accommodates all lenses currently being sold in the market. In addition, the contact lens case are made of polypropylene (96%) and Polyethylene (4%), which allow the same design principle with the same intended use. Speaking of the labeling, the inner lids of the case are marked with L (left) or R (right), meanwhile the bottom of each well is also labeled with L (left) or R (right) to distinguish the left and right lenses. In addition, at the bottom of the case body, two sides of which have labeled REPLACE MONTHLY respectively to remind user to replace the contact lens case at least once every month.
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