510(k) K260694

ZEISS CLINIC 360 by Carl Zeiss Meditec, AG — Product Code NFJ

K260694 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "ZEISS CLINIC 360". The FDA issued a decision of Substantially Equivalent on July 17, 2026. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.