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Found 9 results
510(k) Data Aggregation
K Number
K141164Device Name
ARTEMIS LIGHT ENGINE
Manufacturer
QUEST MEDICAL IMAGING
Date Cleared
2015-03-16
(315 days)
Product Code
NTN
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
Device Description
The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).
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K Number
K133311Device Name
ENDOLED
Manufacturer
OLYMPUS WINTER & IBE GMBH
Date Cleared
2014-07-30
(275 days)
Product Code
NTN
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.
Device Description
The EndoLED is a lightweight portable lamp for the use with endoscopes. The device is battery-operated and uses LEDs to illuminate the area of interest. For the users convenience, the EndoLED come in different designs, the straight and the angled one. The accessories comprise adapters for the use of the EndoLED with different types of endoscopes.
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K Number
K130819Device Name
CLL- V1 LIGHT SOURCE
Manufacturer
OLYMPUS WINTER & IBE GMBH
Date Cleared
2013-06-19
(86 days)
Product Code
NTN, FCW
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Device Description
The Olympus CLL-V1 is a desk top device which consists of a LED light source designed and intended to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
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K Number
K122831Device Name
VIDEO SYSTEM CENTER
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORP.
Date Cleared
2012-12-14
(88 days)
Product Code
NTN, FET, NWB
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This video system center is intended to be used with OLYMPUS video converter, camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
Device Description
The VIDEO SYSTEM CENTER OLYMPUS CV-170 is intended for endoscopic diagnosis, treatment and video observation. The CV-170 is a device which integrates the video processor and the light source. Thus, the CV-170 itself could emit light, capture and process the endoscopic image, and transmit signal to display it on the monitor. The main function of the CV-170 is NBI observation, LED lamp examination, Noise reduction function, Pre-freeze feature, and Color correction.
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K Number
K113679Device Name
LUCEA LED SURGICAL LIGHT SYSTEM
Manufacturer
MAQUET SAS
Date Cleared
2012-01-12
(29 days)
Product Code
NTN, FSS, FTD
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
Device Description
MAQUET LUCEA LED® Surgical Light Systems have been developed in order to provide MAQUET EUGEAEED Surgied Lightnology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. functional shape oners an cindical provide hights provide high quality illumination Designed for minor ourgory, without any compromises on the major enhancements offered by MAQUET surgical lights. The LUCEA LED® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations.
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K Number
K103813Device Name
SOPRO 281
Manufacturer
SOPRO
Date Cleared
2011-03-22
(83 days)
Product Code
NTN, FCW
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy
Device Description
The SOPRO 281 is a light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable. A switch on the top of the device enables light output and intensity control. A multi-color led indicates device status
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K Number
K102167Device Name
LO-50 LED LIGHT SOURCE
Manufacturer
FIBEROPTICS TECHNOLOGY, INC.
Date Cleared
2010-08-17
(15 days)
Product Code
NTN, FCW
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LO-50 LED Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a surgical headlight for general surgical or examination procedures.
Device Description
The LO-50 Light Source is a fiber optic light source using a single solid state light emitting element to produce visible light required to illuminate surgical sites for indirect visualization during medical procedures. The LED produces white light by electroluminescence (as in a tungsten filament lamp) or fluorescence (as in a xenon lamp.) Both of the latter technologies use large amounts of electricity and generate significant heat in creating light. LED generates a greater light output as a percentage of energy input to the lamp. It uses Pulse Width Modulation to control the on/off time of the LED at full output to determine brightness. The LO-50 light source uses a small optical element to capture and direct the light to a port into which one of many common medical light guides may be fitted to conduct the light where needed. The unit consists of the aforementioned LED, cooling fan, light port, sheet metal covers, plastic front and rear covers, and front mounted power switch and dimming control. The unit is very similar in design, format, functionality and size to other light sources including the predicate device.
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K Number
K091829Device Name
PLS PORTABLE LIGHT SOURCE
Manufacturer
OPTIM, INC.
Date Cleared
2009-07-28
(39 days)
Product Code
NTN
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
Device Description
The PLS is a stand-alone, portable, detachable adaptation of the light source embedded into the ENTity NasoView Fiberscope. The PLS is an accessory to endoscopes and other devices that require an external light source.
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K Number
K090601Device Name
FSC 2
Manufacturer
SCHOELLY IMAGING, INC.
Date Cleared
2009-05-11
(67 days)
Product Code
NTN, LED, XXX
Regulation Number
876.1500Why did this record match?
Product Code :
NTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.
Device Description
The Schoelly FSC 2 is a camera hand piece with built-in LED illumination intended to be used with Schoelly endoscopes. The light source provides illumination to the area under endoscopic examination. The compact camera component attaches to the proximal eyepiece of the endoscope via the Flexilock connector. Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.
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