K211868 is an FDA 510(k) clearance for the MYAH. This device is classified as 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 FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K211868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MXK - Device, Analysis, Anterior Segment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |