510(k) K234076

iCare ALTIUS CW by Centervue S.P.A. — Product Code NFJ

K234076 is an FDA 510(k) premarket notification submitted by Centervue S.P.A. for the device "iCare ALTIUS CW". The FDA issued a decision of Substantially Equivalent on August 22, 2024. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Centervue S.P.A. has at least 10 other 510(k) clearances on record.