Stryker Endoscopy · Class II · Cleared Feb 12, 2026
| K-number | K260108 |
| Device name | L12 LED Light Source with AIM |
| Applicant | Stryker Endoscopy |
| Product code | OWN |
| Device class | Class II |
| Decision date | Feb 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The L12 LED Light Source with AIM is an endoscopic imaging system that provides real-time 4K visible white light and near-infrared illumination for surgical visualization. It enables surgeons to assess vessels, blood flow, and tissue perfusion, visualize bile ducts using fluorescence imaging with indocyanine green or pafolacianine, perform cranial neurosurgery and skull base surgery, image the lymphatic system, and transilluminate ureters during minimally invasive and open surgical procedures in adults and pediatric patients.
The subject device has identical technological characteristics to the predicate device (L12 LED Light Source with AIM, K231854), with the sole exception of a modified packaging configuration designed to provide added support during transport.
Non-clinical testing included performance testing of the updated packaging configuration using FDA-recognized voluntary consensus standard ASTM D4169:2022 (14-576) and light output testing (RGBV/NIR) after distribution stress.
The L12 LED Light Source with AIM is substantially equivalent to its predicate because it has the same intended use, indications for use, and fundamental technology. The only change is packaging configuration for transport protection, which does not affect device safety or effectiveness. No clinical studies were required to support substantial equivalence.
View the full FDA submission: accessdata.fda.gov