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    K Number
    K091829
    Device Name
    PLS PORTABLE LIGHT SOURCE
    Manufacturer
    OPTIM, INC.
    Date Cleared
    2009-07-28

    (39 days)

    Product Code
    NTN
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
    Device Description
    The PLS is a stand-alone, portable, detachable adaptation of the light source embedded into the ENTity NasoView Fiberscope. The PLS is an accessory to endoscopes and other devices that require an external light source.
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    K Number
    K080622
    Device Name
    ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
    Manufacturer
    OPTIM, INC.
    Date Cleared
    2008-04-02

    (28 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
    Device Description
    The ENTity NasoView is a modification of the OL-1 Airway Fiberscope. The device has been modified to include a battery-operated LED light source internal to the device control body. An accessory charger is provided for charging the battery outside the scope.
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