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510(k) Data Aggregation

    K Number
    K032309
    Device Name
    NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
    Manufacturer
    Date Cleared
    2003-12-04

    (132 days)

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

    NOVELENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NoveLens® Contact Lens Case is indicated for storage of hard, rigid gas permeable (silicone acrylate and fluro silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
    Device Description
    The NoveLens® Contact Lens Case is a contact Iens storage case comprised of a plastic case that houses two chambers. The upper chamber which holds the lenses separately in individually attached concave reservoirs and a lower chamber that provides space for rinsed solution as it passes through holes from the upper chamber and through a drainage toube into the lower portion of the device. The NoveLens® Contact Lens Case is constructed to take solution introduced into the upper chamber in a rinse fashion and force, by gravity, solution through the drainage holes through a drainage tube and into a lower collecting chamber. Additional solution is added until both chambers are completely filled to the top. Screw caps when closed hermetically seal the system to hold disinfection solution while the lenses are stored and disinfected in accordance with directions consistent with labeled multipurpose contact lens solutions. The design provides for one-way ingress of solution and expulsion of spent solution through external drainage holes from the lower chamber upon tipping the unit on its side.
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