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510(k) Data Aggregation

    K Number
    K163185
    Device Name
    OptiLux LED Illuminator
    Manufacturer
    ISOLUX LLC
    Date Cleared
    2016-11-21

    (7 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISOLUX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Isolux Ilc OptiLux LED Illuminator is indicated for use in transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures.
    Device Description
    Not Found
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    K Number
    K102266
    Device Name
    ISOLED AC-POWERED LED HEADLIGHT SYSTEM
    Manufacturer
    ISOLUX LLC
    Date Cleared
    2010-09-24

    (45 days)

    Product Code
    FST
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISOLUX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.
    Device Description
    Not Found
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    K Number
    K052979
    Device Name
    1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
    Manufacturer
    ISOLUX LLC
    Date Cleared
    2005-10-31

    (7 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISOLUX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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