VISIONSENSE LTD.

VisionSense Ltd. specializes in endoscopic and surgical imaging solutions. Their product range includes endoscopic video cameras—some with infrared capabilities—endoscopic video image processing and light source systems, general-purpose surgical microscopes, fibreoptic light cables, endoscopic remote controls, light source adaptors, and manually-adjusted surgical instrument assist arms. These devices are designed to support high-resolution imaging and precise lighting in surgical and diagnostic procedures.

VisionSense Ltd. is headquartered in the United States. The company’s location ensures alignment with US regulatory frameworks, including those governing medical device classification and compliance.

VisionSense Ltd.’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance with US medical device regulations, helping to track and monitor devices throughout their lifecycle.

VisionSense Ltd.’s devices fall into either Class I or Class II categories under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.