K121738 is an FDA 510(k) clearance for the MYVISIONTRACK(TM). This device is classified as a Grid, Amsler (Class I - General Controls, product code HOQ).
Submitted by Vital Art and Science Incorporated (Richardson, US). The FDA issued a Cleared decision on February 22, 2013, 254 days after receiving the submission on June 13, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1330.
| 510(k) Number | K121738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2012 |
| Decision Date | February 22, 2013 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HOQ — Grid, Amsler |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1330 |