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    K Number
    K140812
    Device Name
    MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Date Cleared
    2014-08-07

    (128 days)

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

    MEDICAL ILLUMINATION INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MI-750 is a fixed pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
    Device Description
    The proposed MI-750 is a first generation fix pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
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    K Number
    K100388
    Device Name
    21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Date Cleared
    2010-06-22

    (126 days)

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

    MEDICAL ILLUMINATION INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 21tt Century Centurion ExceLED and System Two LED lights are intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures. The System Two LED surgical Lighting System is an AC powered device which provides a focusable filed of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below. All 3 models will have 5-level dimming and beam size (8"-12") adjustments. D1 = small minor surgical light / satellite - D2 = large minor surgical light D3 = major surgical light
    Device Description
    The proposed 21* Century Centurion ExceLED (an AC powered device) is the first generation fixed pattern / five level intensity minor surgical LED (Light Emitting Diode) light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures. The proposed System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below. All 3 models will have 5-level dimming and beam size (8"-12") adjustments. - D1 = small minor surgical light / satellite - D2 = large minor surgical light - D3 = major surgical light
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    K Number
    K053227
    Device Name
    LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Date Cleared
    2006-01-13

    (57 days)

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

    MEDICAL ILLUMINATION INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Illumination International Inc. 150 - 300 Watt Medical Fiberoptic Light Source with Headlight is indicated for use in transmitting light for illumination purposes from an illuminator (150 - 300 Watt Lamp) to various instruments such as a Headlight, providing illumination in body cavities during examinations or minimal invasive surgical procedures.
    Device Description
    Not Found
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    K Number
    K010495
    Device Name
    CENTURA PHOTOTHERAPY SPOTLIGHT
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Date Cleared
    2001-03-09

    (17 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL ILLUMINATION INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003489
    Device Name
    NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Date Cleared
    2001-02-02

    (81 days)

    Product Code
    FSS, FSY, FTD
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL ILLUMINATION INTERNATIONAL, INC.

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

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