510(k) K160327

ALADDIN HW3.0 by Visia Imaging S.R.L. — Product Code HJO

K160327 is an FDA 510(k) premarket notification submitted by Visia Imaging S.R.L. for the device "ALADDIN HW3.0". The FDA issued a decision of Substantially Equivalent on October 5, 2016. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Visia Imaging S.R.L. has at least 3 other 510(k) clearances on record.