K140026 is an FDA 510(k) clearance for the COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST. This device is classified as a Plug, Punctum.
Submitted by Lacrimedics, Inc. (Du Pont, US). The FDA issued a Cleared decision on June 3, 2014, 148 days after receiving the submission on January 6, 2014.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K140026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2014 |
| Decision Date | June 03, 2014 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU — Plug, Punctum |
| Device Class | — |