510(k) K180526

EIDON FA by Centervue S.P.A. — Product Code MYC

K180526 is an FDA 510(k) premarket notification submitted by Centervue S.P.A. for the device "EIDON FA". The FDA issued a decision of Substantially Equivalent on July 16, 2018. 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.