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510(k) Data Aggregation

    K Number
    K130930
    Device Name
    OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
    Manufacturer
    NINGBO LISHUNDA ELECTRONICS CO., LTD.
    Date Cleared
    2014-02-12

    (314 days)

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

    NINGBO LISHUNDA ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "OWL Contact Lens Case" and "DOG Contact Lens Cases" are a device 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 "OWL Contact Lens Case" and "DOG Contact Lens Case" are medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. "OWL Contact Lens Case" has a well diameter of 27 mm, well capacity of 5.5 mL, and overall dimension of 71 x 38.5 x 17 mm (length x width x height). The case body is in blue color and case lids are in white and black colors. Inside of the lid has only white color and has no black color. "DOG Contact Lens Case" has a well diameter of 25 mm, well capacity of 4.8 mL, and dimension of 69.5 x 38 x 14 mm (length x width x height). The case body is in blue color and case lids are in blue, black and white color. Inside of the lid has only blue color and has no white and black color. Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right). The applicant device of Contact Lens Case is made of Acrylonitrile - butadiene - styrene copolymer (ABS).
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