LED Light Source with AIM Technology

LED Light Source with AIM Technology
L10 - 0220220300

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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