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510(k) Data Aggregation

    K Number
    K014162
    Device Name
    MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
    Manufacturer
    LOBOB LABORATORIES, INC.
    Date Cleared
    2002-01-15

    (27 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOBOB LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses
    Device Description
    The product is a sterile solution containing lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.
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    K Number
    K001964
    Device Name
    OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
    Manufacturer
    LOBOB LABORATORIES, INC.
    Date Cleared
    2000-07-18

    (21 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOBOB LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001428
    Device Name
    OPTIMUM WETTING AND REWETTING DROP
    Manufacturer
    LOBOB LABORATORIES, INC.
    Date Cleared
    2000-05-26

    (21 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOBOB LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K990044
    Device Name
    LOBOB UNIVERSAL CONTACT LENS CLEANER
    Manufacturer
    LOBOB LABORATORIES, INC.
    Date Cleared
    1999-02-11

    (36 days)

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

    LOBOB LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To clean soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-sillcone acrylate) and hard (PMA) contact lenses.
    Device Description
    The device is currently marketed as a cleaner for rigid gas permeable (RGP) and hard (PMMA) contact lenses. The current notification is for the added indication of cleaning soft (hydrophilic) contact lenses.
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