510(k) K200254

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) by Optina Diagnostics — Product Code HKI

K200254 is an FDA 510(k) premarket notification submitted by Optina Diagnostics for the device "Mydriatic Hyperspectral Retinal Camera (MHRC-C1)". The FDA issued a decision of Substantially Equivalent on April 27, 2020. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Optina Diagnostics has at least 2 other 510(k) clearances on record.