510(k) K222933

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

K222933 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 June 29, 2023. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2023
Date Received
September 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type