510(k) K254242

KARL STORZ ICG Imaging System with RUBINA® Lens by Karl Storz SE & CO. KG — Product Code OWN

K254242 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "KARL STORZ ICG Imaging System with RUBINA® Lens". The FDA issued a decision of Substantially Equivalent on February 26, 2026. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.