Submission Details
| 510(k) Number | K211786 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Independent Corneal Viewing Chamber (IVC-21)
Dec 2021
Decision
177d
Days
—
Risk
About This 510(k) Submission
K211786 is an FDA 510(k) clearance for the Independent Corneal Viewing Chamber (IVC-21), 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 review panel.
Device Classification
| Product Code | LYX — Media, Corneal Storage |
| Device Class | — |
Manufacturer
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