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510(k) Data Aggregation

    K Number
    K121030
    Device Name
    SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
    Date Cleared
    2012-07-06

    (92 days)

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

    SACKS HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
    Device Description
    The applicant contact lens case is a lens care product used by the contact lens wearer or practitioner for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only. Not to be used with heat. This device is manufactured in two variations: clear cap/blue cap and clear base and clear cap/green cap and clear base. The variants follow the same design and have the same intended use. The only difference is the color appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The right cap is labeled with the Letter 'R' to distinguish right and left lenses. The primary materials which compose the applicants device are M800E Polypropylene produced by Sinopec Shanghai Petrochemical Company Limited Plastics Division which is a translucent raw material and Heliogen Blue K6911D and Heliogen Green K8730 by BASF Corporation used as color additives. The applicant device of Contact Lens Case consists of 2 parts: case bottom (body) and case caps (covers). The volume of each of the two chambers in the applicant device is 3.8ml and the inner height of both wells is 10mm. The capacity of each well is sufficient for contact lens to be fully immersed under use conditions and can accommodate all lenses currently on the market.
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