510(k) K180378

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module by Optomed OY — Product Code HKI

K180378 is an FDA 510(k) premarket notification submitted by Optomed OY for the device "Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module". The FDA issued a decision of Substantially Equivalent on April 5, 2018. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Optomed OY has at least 7 other 510(k) clearances on record.