K213988 is an FDA 510(k) clearance for the SOFT PLUG Extended Duration 180 Tapered Canalicular Plug. This device is classified as a Plug, Punctum.
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 3, 2022, 165 days after receiving the submission on December 20, 2021.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K213988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2021 |
| Decision Date | June 03, 2022 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU - Plug, Punctum |
| Device Class | - |