LED Light Source with AIM Technology
L10 - 0220220300
Device Description
A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OWN
Device Name: Confocal Optical Imaging
Device Class: 2
Physical State: Usually include optical fibers, light collection cameras and computer-based central processing unit
Definition: Collection of light signals for visualization of cellular microstructures.
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Collects reflected and scattered light signals from the areas of interest for image reconstruction
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: soft tissue, blood vessel and other vessels in the body
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device Identifiers
Device Id: 07613327051377
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
