K211786 is an FDA 510(k) clearance for the Independent Corneal Viewing Chamber (IVC-21). This device is classified as a Media, Corneal Storage.
Submitted by Bausch & Lomb, Incorporated (St. Louis, US). The FDA issued a Cleared decision on December 3, 2021, 177 days after receiving the submission on June 9, 2021.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K211786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2021 |
| Decision Date | December 03, 2021 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LYX — Media, Corneal Storage |
| Device Class | — |