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510(k) Data Aggregation

    K Number
    K161622
    Device Name
    LensGiene Sterile Saline Solution
    Manufacturer
    Optics Laboratory, Inc.
    Date Cleared
    2016-08-11

    (59 days)

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

    Optics Laboratory, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LensGiene™ Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The LensGiene™ Sterile Saline Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
    Device Description
    The LensGiene™ Sterile Saline Solution is a sterile, preservative-free, aqueous solution of sodium chloride, boric acid, and sodium borate provided in single does, carry-on size 10 ml bottles. The sterile saline solution has a pH 7.2-7.8 and a tonicity of 290-320 mOsm/kg. It rinses loose debris and cleaning solution off soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner. The sterile saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time. The LensGiene™ Sterile Saline Solution is a clear solution and should not be used if cloudy or discolored. The individual 10 ml bottle should be discarded after opening and use and should not be used after its labeled expiry date.
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    K Number
    K110221
    Device Name
    EYE-CEPT STERILE SALINE SOLUTION
    Manufacturer
    OPTICS LABORATORY, INC
    Date Cleared
    2011-11-01

    (280 days)

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

    OPTICS LABORATORY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eye-Cept® Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use.
    Device Description
    Eye-Cept® Sterile Saline Solution is provided in single use, carry-on size bottles that are preservative free. It rinses loose debris and cleaning solution off soft (hydrophilic) contact lenses. It is only for use to rinse and wet soft contact lenses (a) after cleaning before disinfection and (b) after disinfection before using. It is not a disinfectant nor should it be used as eye drops. It is a clear solution and should not be used, if cloudy or discolored. The individual 10 ml bottle should not be kept once used; it should be discarded after opening. It should not be used after its labeled expiry date.
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    K Number
    K041008
    Device Name
    EYE-CEPT REWETTING DROPS
    Manufacturer
    OPTICS LABORATORY, INC.
    Date Cleared
    2005-07-01

    (438 days)

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

    OPTICS LABORATORY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use EYE-CEPT® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use EYE-CEPT Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
    Device Description
    Not Found
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