510(k) K213705

DRSplus by Centervue S.P.A. — Product Code MYC

K213705 is an FDA 510(k) premarket notification submitted by Centervue S.P.A. for the device "DRSplus". The FDA issued a decision of Substantially Equivalent on Dec 21, 2021. 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 12 other 510(k) clearances on record.