Profile: LuxteL LLC® offers vertically integrated headlights and video cameras trademarked IsoluX. We specialize in xenon light source illuminators and medical video camera systems that use CeraLux xenon lamps for a high-intensity white light, such as 6000°K color temperature. Our IsoluX fiber optic illuminators are available in 125W, 180W and 300W power levels. They render true tissue color, enabling clarity of retinal vision. Our 300W xenon illuminator has a dimension of 6"H x 11"W x 12"D with a weight of 14 lbs. It has re-settable digital time meter that indicates elapsed number of lamp hours. It has a low noise fan and down-flow cooling system. The xenon lamp module provides from 600 to 1000 hours of lamp life, depending upon usage. Our IsoLED headlight is designed for examination, minimally invasive surgeries, and dental & veterinary use. Its LEDs are closely coupled to the optics, enabling the focused light to be even and uniform, edge to edge. It has a life expectancy of 50,000 hours.
FDA Registration Number: 1064515
9 Products/Services (Click for related suppliers)
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| • Battery-Operated Operating Headlamp (FDA Code: HPP / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures. |
| • Endoscopic Camera without Audio (FDA Code: FWL / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |
| • Fiberoptic Illuminator for Endoscope (FDA Code: FFS / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
| • Fiberoptic Surgical Light (FDA Code: FST / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. |
| • Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. |
| • Surgical Field Fiberoptic Illuminator (FDA Code: HBI / 878.4580) |
| • Surgical Still Camera (FDA Code: FTT / 878.4160) |
| • Surgical Television Camera without Audio (FDA Code: FWB / 878.4160) |
| • Xenon Arc Lamp |