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510(k) Data Aggregation

    K Number
    K131226
    Device Name
    NOVAPROBE LED LIGHT SOURCE
    Manufacturer
    NOVAPROBE INCORPORATED
    Date Cleared
    2014-07-24

    (450 days)

    Product Code
    FCW, NTN
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
    Device Description
    The NOVAPROBE LED LEUKOS 175 is specifically designed to provide the cold light intensity required for modern day Endoscopic procedures. The LED light provides the color temp of 6500 deg K also known as white light. The white light offers unmatched quality for the single chip, three chip and HD cameras. The LED light intensity is controlled digitally. Using LED nullifies any skin burning problems that may occur due to the use of arc lamps. The NovaProbe LED Light source assures that the light passing through the fiber optic cable is a cold light.
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    K Number
    K123956
    Device Name
    POWER LED 175
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2013-01-25

    (35 days)

    Product Code
    FCW, NTN, POW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.
    Device Description
    The power LED 175 is a high power medical cold light source used for endoscopic diagnostic and surgical procedures. The device can be controlled via buttons on the front panel or via SCB (STORZ Communication Bus). This device provides high light intensity at low power consumption with intelligent cooling concept for minimal noise emission. This device includes a cold light source power LED 175, power cord, and the 100 cm SCB connection cable. The light is transmitted through an optical cable and a scope to illuminate surgical sites during minimally invasive surgical procedures.
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    K Number
    K123359
    Device Name
    OVS1 VIDEO SYSTEM
    Manufacturer
    OLIVE MEDICAL CORP.
    Date Cleared
    2012-12-19

    (49 days)

    Product Code
    FCW, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OVS 1 Video System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable
    Device Description
    The OVS I Video System is a Camera Control Unit with integrated LED Light Source and Video Display for use in a surgical environment to view endoscopic images when interfaced with the Olive Medical TCK I HD Camera Head, an endoscope, a light cable, and other accessory devices.
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    K Number
    K121724
    Device Name
    ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    2012-09-20

    (100 days)

    Product Code
    FCW, NTN
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOLIGHT LED Light Source Projector is intended to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.
    Device Description
    The ENDOLIGHT LED Light Source is a fiber optic light source utilizing a single, solid state, high power, white light emitting diode (LED) to produce visible light that used to illuminate surgical sites during minimally invasive surgical procedures. The light from the ENDOLIGHT LED Light Source is transmitted through an optical cable and a scope. ENDOLIGHT LED 1.1 and 1.2 are comprised of light source and power supply cord. The units consist of aforementioned LED, cooling fan, light port, and protective housing. ENDOLIGHT LED 1.1 and 1.2 are portable and are very similar in design, format, and functionality to other LED light sources including the predicate devices. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.
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    K Number
    K093792
    Device Name
    LED LIGHT SOURCE
    Manufacturer
    SUNOPTIC TECHNOLOGIES, LLC
    Date Cleared
    2010-03-18

    (98 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.
    Device Description
    LED Light Source (LLS-050 LED Illuminator)
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    K Number
    K091968
    Device Name
    KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2009-09-14

    (75 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz LED NOVA 100 Cold Light Fountain is indicated for use to transmit light through an optical cable to an endoscope in order to illuminate the site of surgery during minimally invasive endoscopic surgical procedures.
    Device Description
    Not Found
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    K Number
    K082813
    Device Name
    STRYKER LED LIGHTSOURCE
    Manufacturer
    STRYKER CORP.
    Date Cleared
    2008-12-19

    (86 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
    Device Description
    The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
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    K Number
    K081477
    Device Name
    LUXTEC MLX LIGHT SOURCE
    Manufacturer
    INTEGRA LUXTEC, INC.
    Date Cleared
    2008-06-18

    (22 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. The Integra Luxtec MLX Light Source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye.
    Device Description
    Not Found
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    K Number
    K032430
    Device Name
    ACUEITY MEDICAL LIGHT SOURCE
    Manufacturer
    ACUEITY, INC.
    Date Cleared
    2003-09-05

    (30 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.
    Device Description
    The Medical Light Source was specifically designed for medical applications. Therefore, the highest safety requirements for the patient as well as for the physician are applied. The Light Source combines highest illumination requirements with high-resolution video capabilities through an integrated highresolution ¼", ½" or 1/3" CCD camera board.
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    K Number
    K012265
    Device Name
    METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
    Manufacturer
    CIRCON VIDEO
    Date Cleared
    2001-10-17

    (90 days)

    Product Code
    FCW, FCR, FFS, GCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FCW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the Metal Halide Light Sources is to provide optimized light for viewing procedures carried out with flexible and rigid endoscopes.
    Device Description
    Metal Halide Light Sources Models, MV-9088-T and MV-9088
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