510(k) K211868

MYAH by Visia Imaging S.R.L. — Product Code MXK

K211868 is an FDA 510(k) premarket notification submitted by Visia Imaging S.R.L. for the device "MYAH". The FDA issued a decision of Substantially Equivalent on March 1, 2022. The device falls under product code MXK (Device, Analysis, Anterior Segment), 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.