K190210 is an FDA 510(k) clearance for the Tear Pool Dissolvable Punctum Plugs. This device is classified as a Plug, Punctum.
Submitted by Alphamed, Inc. (El Paso, US). The FDA issued a Cleared decision on October 24, 2019, 262 days after receiving the submission on February 4, 2019.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K190210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2019 |
| Decision Date | October 24, 2019 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU - Plug, Punctum |
| Device Class | - |