Cleared Traditional

MYAH

K211868 · Visia Imaging S.R.L. · Ophthalmic
Mar 2022
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K211868 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 March 1, 2022, 258 days after receiving the submission on June 16, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K211868 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2021
Decision Date March 01, 2022
Days to Decision 258 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