SmartsurgN, Inc. · Class II · Cleared Apr 20, 2026
| K-number | K242163 |
| Device name | SmartSurgN Visualization System |
| Applicant | SmartsurgN, Inc. |
| Product code | OWN |
| Device class | Class II |
| Decision date | Apr 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The SmartSurgN Visualization System provides real-time endoscopic visible light and near-infrared (NIR) fluorescence imaging during minimally invasive surgery. When used with indocyanine green (ICG), it enables surgeons to visualize vessels, blood flow, tissue perfusion, and major bile ducts. The system is not intended for standalone biliary duct visualization and must be used with standard white light and intraoperative cholangiography when indicated.
The device uses 4K, 4CMOS video signal processing with LED illumination and NIR laser excitation. It comprises an EyeRSurgN Console with PrizMCurgN Camera Head, IRLightSurgN Light Source, and OptIcRSurgN 10mm ICG Laparoscope (0° or 30°). The laparoscope maintains the same diameter, working length (31 cm), field of view (70°), materials (stainless steel, epoxy, sapphire, PEEK), and reusability as the predicate device.
IEC 60601-1-1:2005, IEC 60601-1-2:2014, EN IEC 60825-1:2014 (laser safety), ISO 8600-5:2020 (optical resolution), ISO 8600-3:2019 (field of view), IEC 62304:2006 (software lifecycle), ISO/IEC 27000:2016 (information security), and ISTA 2A-2011 (packaging).
The subject device has the same intended use, indications, and technological characteristics as the predicate device K213943, with no changes to the imaging console, camera head, light source, or system operation. Software updates improve reliability and usability without altering core function. The addition of laparoscope suppliers and a 4K video recorder do not change the fundamental design or performance. Non-clinical testing confirms the device is as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov