K222164 is an FDA 510(k) clearance for the Visant Medical Canalicular Plug. This device is classified as a Plug, Punctum.
Submitted by Visant Medical, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 23, 2022, 155 days after receiving the submission on July 21, 2022.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K222164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2022 |
| Decision Date | December 23, 2022 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU - Plug, Punctum |
| Device Class | - |