K222933 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 June 29, 2023, 276 days after receiving the submission on September 26, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K222933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MXK - Device, Analysis, Anterior Segment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |