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510(k) Data Aggregation

    K Number
    K091246
    Device Name
    ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Date Cleared
    2009-09-28

    (154 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".
    Device Description
    The iLED surgical light mobile family is suitable for all types of surgical procedures. TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters. The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.
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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?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984124
    Device Name
    AESCULAP XENON LIGHT SOURCE
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    1999-02-01

    (75 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.
    Device Description
    The Xenon Light Source consists of a light source control unit and fiber optic cables. Technological characteristics are provided below: Design: Light Source in stainless steel / aluminum housing Dimensions: 305mm x 305mm x 82mm Weight: 6.5kg Lamp: 180W Xenon Circuit: Transistorized Voltage: 100 - 240V AC Power Freq.: 50 - 60 HZ
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    K Number
    K981962
    Device Name
    CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-08-18

    (75 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.
    Device Description
    Lightsource or illuminator M-300
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    K Number
    K981821
    Device Name
    VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-07-29

    (68 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES 3001/w use is indicated in the following situations: - Whenever there is a need for head lamp illumination of the fiber-optic type . - When ever there is a need for a fiber-optic illuminator for an endoscope . - . When ever there is a need to use video either as a visual aid for as a method of recording or both. - When ever there is a requirement for any or all of the above at the same . time.
    Device Description
    Not Found
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    K Number
    K981469
    Device Name
    CERMAX300 LIGHTSOURCE
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-07-09

    (77 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.
    Device Description
    Lightsource or illuminator CERMAX300
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    K Number
    K980044
    Device Name
    XENON 300MX
    Manufacturer
    PERKINELMER OPTOELECTRONICS
    Date Cleared
    1998-04-03

    (87 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EG&G Xenon 300mx is intended to be used with fiber optic cables for endoscopes, surgical headlamps and other lighted tools that contain fiber optic bundles. Illumination from this device is to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, borncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various surgical procedures. The Xenon 300mx Illuminator is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contained Fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs, and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology, and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.
    Device Description
    EG&G Optoelectronics has engineered the Xenon 300mx to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon Lamp with focusing optics, a variable light attenuator, a selector for four standard fiber optic cable sizes, and a forced air cooling system.
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    K Number
    K970886
    Device Name
    HANAULUX BLUE 80 HOSPITAL
    Manufacturer
    HERAEUS MED GMBH
    Date Cleared
    1997-04-16

    (69 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light.
    Device Description
    Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.
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    K Number
    K961971
    Device Name
    Q-5000
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    1996-06-28

    (39 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Endoscopy Q-5000 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 endoscopy (general, gastroenterological and ENT surgery).
    Device Description
    The Stryker Endoscopy Q-5000 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 endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope. The light source is an integral component of a visualization system which consist of the a video camera, a video monitor, a light cable and a scope. The Q-5000 light source is AC powered and is designed to meet international medical devices safety standards (IEC 601-1, UL, CSA) to provide safe operation and eliminates or minimizes risks of burns, fire, explosion eye damage, electromagnetic interference or electrical shock that may be associated with it.
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    K Number
    K961074
    Device Name
    LIGHTSOURCE OR ILLUMINATOR
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1996-04-30

    (43 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FSS

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

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