510(k) K232944

CALLISTO eye by Carl Zeiss Meditec, AG — Product Code NFJ

K232944 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "CALLISTO eye". The FDA issued a decision of Substantially Equivalent on December 21, 2023. 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.