The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the endoscopic light-projecting measuring device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · June 22, 2026
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
FDA classifies endoscopic light-projecting measuring device into class II with special controls to ensure safety and effectiveness.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.