510(k) K243504

MAIA (AHMACME001) by Centervue S.P.A. — Product Code MYC

K243504 is an FDA 510(k) premarket notification submitted by Centervue S.P.A. for the device "MAIA (AHMACME001)". The FDA issued a decision of Substantially Equivalent on March 17, 2025. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570. Centervue S.P.A. has at least 10 other 510(k) clearances on record.