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Found 25 results
510(k) Data Aggregation
K Number
K200874Device Name
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
Manufacturer
Innovasis, Inc.
Date Cleared
2020-06-30
(90 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.
Device Description
The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources.
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K Number
K141330Device Name
ENDO-CORD
Manufacturer
ENROXTECH, INC.
Date Cleared
2014-12-15
(208 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to transmit light for illumination purposes from the light source to endoscopes.
Device Description
A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet. Field replaceable fiber-optic core.
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K Number
K122637Device Name
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
Manufacturer
STRYKER SPINE
Date Cleared
2012-11-01
(64 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.
Device Description
The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.
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K Number
K113697Device Name
EIGR SURGICAL ILLUMINATION SYSTEM
Manufacturer
INVUITY, INC.
Date Cleared
2012-02-10
(56 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.
Device Description
Not Found
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K Number
K113330Device Name
CABLECAP
Manufacturer
SENSORMED
Date Cleared
2012-01-12
(59 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.
Device Description
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.
There are three separate models made for the three types of light cables:
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K Number
K102266Device Name
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
Manufacturer
ISOLUX LLC
Date Cleared
2010-09-24
(45 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.
Device Description
Not Found
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K Number
K101496Device Name
CABLECAP MODEL: WLF, STZ, ACM
Manufacturer
SENSORMED
Date Cleared
2010-09-14
(105 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. It is necessary to check each light cable to determine which CableCap model (STZ, ACM, WLF) to use. See product instructions for cleaning and sterilization protocols.
The device is not intended to be used to illuminate the surgical field.
Device Description
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.
There are three separate models made for the three types of light cables: WLF, STZ, ACM.
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K Number
K100388Device Name
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
Manufacturer
MEDICAL ILLUMINATION INTERNATIONAL, INC.
Date Cleared
2010-06-22
(126 days)
Product Code
FST, FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 21tt Century Centurion ExceLED and System Two LED lights are intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.
The System Two LED surgical Lighting System is an AC powered device which provides a focusable filed of illumination for general examination and surgery.
It can consist of any combination of the 3 lights (D1, D2, D3) listed below.
All 3 models will have 5-level dimming and beam size (8"-12") adjustments.
D1 = small minor surgical light / satellite
- D2 = large minor surgical light
D3 = major surgical light
Device Description
The proposed 21* Century Centurion ExceLED (an AC powered device) is the first generation fixed pattern / five level intensity minor surgical LED (Light Emitting Diode) light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
The proposed System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below.
All 3 models will have 5-level dimming and beam size (8"-12") adjustments.
- D1 = small minor surgical light / satellite
- D2 = large minor surgical light
- D3 = major surgical light
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K Number
K100395Device Name
HARMONY VLED SURGICAL LIGHTNING SYSTEM
Manufacturer
STERIS Corporation
Date Cleared
2010-03-17
(29 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
Device Description
The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
The Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities.
The Harmony vLED Surgical Lighting System accessories are as follows:
- STERIS ACT Interface o
- o Camera Module
- Dual or Single Flat Panel Monitors o
- o 24VDC Battery Backup support
- Remote Power Module Unit 0
- Sterile Disposable Handle Covers o
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K Number
K093386Device Name
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
Manufacturer
BFW, INC
Date Cleared
2010-01-28
(90 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Product Code :
FST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.
The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.
Device Description
The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems. Its' intended function and use is to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.
The XtremeBeam Fiber Optic Headlight is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures. It is constructed of a durable plastic housing, lenses, spot size adjustment, and positioning bar. It utilizes a proprietary fiber optic cable, the distal end of which will fit an ACMI port. The luminaire optics consist of optic lenses, a mirror, and an iris.
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