510(k) K162778

Portable Slit Lamp Microscope by Suzhou Kangjie Medical, Inc. — Product Code HJO

K162778 is an FDA 510(k) premarket notification submitted by Suzhou Kangjie Medical, Inc. for the device "Portable Slit Lamp Microscope". The FDA issued a decision of Substantially Equivalent on July 21, 2017. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850.