510(k) K221111

Non-Mydriatic Retinal Camera NW500 by Topcon Corporation — Product Code HKI

K221111 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "Non-Mydriatic Retinal Camera NW500". The FDA issued a decision of Substantially Equivalent on August 29, 2022. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Topcon Corporation has at least 10 other 510(k) clearances on record.