Cleared Traditional

MYAH

K222933 · Visia Imaging S.R.L. · Ophthalmic
Jun 2023
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K222933 is an FDA 510(k) clearance for the MYAH, a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Visia Imaging S.R.L. (San Giovanni Valdarno, IT). The FDA issued a Cleared decision on June 29, 2023, 276 days after receiving the submission on September 26, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K222933 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2022
Decision Date June 29, 2023
Days to Decision 276 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code MXK — Device, Analysis, Anterior Segment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850