K162361 is an FDA 510(k) clearance for the Soft Plug Extended Duration 180 Canalicular Plug. This device is classified as a Plug, Punctum.
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on April 17, 2017, 237 days after receiving the submission on August 23, 2016.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K162361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2016 |
| Decision Date | April 17, 2017 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU - Plug, Punctum |
| Device Class | - |