510(k) K193188

MiiS Horus Eye Anterior Camera by Medimaging Integrated Solution, Inc (Miis) — Product Code HJO

K193188 is an FDA 510(k) premarket notification submitted by Medimaging Integrated Solution, Inc (Miis) for the device "MiiS Horus Eye Anterior Camera". The FDA issued a decision of Substantially Equivalent on January 14, 2020. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Medimaging Integrated Solution, Inc (Miis) has at least 6 other 510(k) clearances on record.