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510(k) Data Aggregation
K Number
K001698Device Name
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
Manufacturer
COGENT LIGHT TECHNOLOGIES, INC.
Date Cleared
2000-07-17
(45 days)
Product Code
FFS, FST, HBI, KOD
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
COGENT LIGHT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983714Device Name
SOLARTEC SOURCE 270, MODEL # 90123
Manufacturer
COGENT LIGHT TECHNOLOGIES, INC.
Date Cleared
1998-12-23
(63 days)
Product Code
FFS
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
COGENT LIGHT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SolarTec™ Source 270 System is intended for use:
1. To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical headlamps that contain fiber bundles or single fibers for illumination
2. In providing illumination for the purposes of allowing observation and manipulation of body cavities and tissues, hollow organs, and canals.
3. With applications that include, but are not limited to, headlights and/or externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.
Device Description
The Subject Device is designed with a safety interlock on the lamp replacement door. If the cover is opened, the power to the device will be interrupted. The Subject Device is cooled with a forced air fan to prevent the temperature of the unit from exceeding a safe level. If in the event that the fan malfunctions and/or fails to operate properly and the internal temperature of the device exceeds the engineered specifications, the device is designed with an internal thermal protection mechanism that automatically shuts off the power to the lamp. The Subject Device contains a user replaceable lamp fixture. The Subject Device has incorporated several safety features into the product design. These safety features include: a) The lamp is never operated beyond its specified power range, b) The lamp life is limited to approximately 1000 hours by analog circuitry. This limit is significantly below the safe rated life expectancy of the lamp (approximately 4000 hours) as stated by the lamp manufacturer, c) The enclosure has interlor structures (baffles), which will dampen the sound level and confine any debris which might result from the non-passive lamp failure. The Subject Device used with a Cogent Light single fiberoptic cable typically produces a uniform output image.
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K Number
K971057Device Name
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
Manufacturer
COGENT LIGHT TECHNOLOGIES, INC.
Date Cleared
1997-03-28
(4 days)
Product Code
GCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
COGENT LIGHT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Both devices are intended for the same use, that of providing visible light for the illumination of surgical headlights and various rigid or flexible endoscopes that contain fiber bundles for illumination. Applications for both systems include, but are not limited to, externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhino-laryngoscopy, urology, and vascular endoscopy.
Device Description
Both devices consist of a light source control box which houses a Xenon lamp, power supply, and connects to a proprietary fiberoptic cable. With a fiber bundle adapter, this illuminator can also be used with regular fiber bundle optic cables and headlamps.
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