OPTOVISION Endoscopic Light Source Unit
Optosurgical LLCThe OPTOVISION Endoscopic Light Source Unit by Optosurgical LLC is a device designed to provide real-time visible and near-infrared fluorescence imaging during endoscopic procedures. Using indocyanine green (ICG) dye, it helps surgeons visualize vessels, blood flow, tissue perfusion, lymphatic systems, and bile ducts to aid minimally invasive surgeries, improving surgical precision and patient outcomes.
Intended Use
The OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging to enable minimally invasive surgery, with visual assessment of vessels, blood flow, tissue perfusion, major extra-hepatic bile ducts, and lymphatic system visualization using ICG.
Technology
The device consists of an endoscopic light source unit with power and control circuits and a lighting lamp. It uses RGB LEDs and a near-infrared laser diode combined via dichroic mirrors to project white and near-infrared light through a fiber output bundle into an endoscope, enabling both visible-light imaging and near-infrared fluorescence imaging with ICG.
Performance
The device underwent electrical safety, electromagnetic compatibility, usability, photobiological safety, software validation, and bench performance testing according to recognized standards, all of which passed, demonstrating compliance with applicable safety standards and intended performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/20/2024
3 months - 2
FDA Approval
2/19/2025
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