The following data is part of a premarket notification filed by Bausch + Lomb, Incorporated with the FDA for Independent Corneal Viewing Chamber (ivc-21).
| Device ID | K211786 |
| 510k Number | K211786 |
| Device Name: | Independent Corneal Viewing Chamber (IVC-21) |
| Classification | Media, Corneal Storage |
| Applicant | Bausch + Lomb, Incorporated 3365 Tree Court Industrial Boulevard St. Louis, MO 63122 |
| Contact | Heather Christie |
| Correspondent | Heather Christie Bausch + Lomb, Incorporated 3365 Tree Court Industrial Boulevard St. Louis, MO 63122 |
| Product Code | LYX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-09 |
| Decision Date | 2021-12-03 |