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510(k) Data Aggregation

    K Number
    K160005
    Device Name
    Contact Lens Case (multiple brand name)
    Manufacturer
    DANYANG CHANXIN GLASSES CASES FACTORY
    Date Cleared
    2016-06-07

    (155 days)

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

    DANYANG CHANXIN GLASSES CASES FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.
    Device Description
    Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection. There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use. All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition.
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