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Found 10 results
510(k) Data Aggregation
K Number
K091246Device 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
878.4580Why 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
K003489Device 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
878.4580Why 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
K984124Device Name
AESCULAP XENON LIGHT SOURCE
Manufacturer
AESCULAP, INC.
Date Cleared
1999-02-01
(75 days)
Product Code
FSS
Regulation Number
878.4580Why 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
K981962Device 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
878.4580Why 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
K981821Device Name
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
Manufacturer
ANGIOLAZ, INC.
Date Cleared
1998-07-29
(68 days)
Product Code
FSS
Regulation Number
878.4580Why 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
K981469Device Name
CERMAX300 LIGHTSOURCE
Manufacturer
CUDA PRODUCTS CO.
Date Cleared
1998-07-09
(77 days)
Product Code
FSS
Regulation Number
878.4580Why 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
K980044Device Name
XENON 300MX
Manufacturer
PERKINELMER OPTOELECTRONICS
Date Cleared
1998-04-03
(87 days)
Product Code
FSS
Regulation Number
878.4580Why 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
K970886Device Name
HANAULUX BLUE 80 HOSPITAL
Manufacturer
HERAEUS MED GMBH
Date Cleared
1997-04-16
(69 days)
Product Code
FSS
Regulation Number
878.4580Why 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
K961971Device Name
Q-5000
Manufacturer
Stryker Endoscopy
Date Cleared
1996-06-28
(39 days)
Product Code
FSS
Regulation Number
878.4580Why 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
K961074Device Name
LIGHTSOURCE OR ILLUMINATOR
Manufacturer
CUDA PRODUCTS CO.
Date Cleared
1996-04-30
(43 days)
Product Code
FSS
Regulation Number
878.4580Why did this record match?
Product Code :
FSS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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