Independent Corneal Viewing Chamber (IVC-21)
FDA 510(k) K211786 · Bausch + Lomb, Incorporated
510(k) numberK211786
Submission
- Device name
- Independent Corneal Viewing Chamber (IVC-21)
- Applicant
- Bausch + Lomb, Incorporated
St. Louis, MO, US - Received
- June 9, 2021
- Decision date
- December 3, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYX – Media, Corneal Storage
- Device class
- Unclassified
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| K954548 | The Chen MediumLYX · Traditional | Chen Ophthalmic Laboratories | 05/20/1996SE |
| K924165 | Optisol-Gs Corneal Storage MediaLYX · Traditional | Chiron Intraoptics | 10/06/1992SE |
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Questions and answers
When was Independent Corneal Viewing Chamber (IVC-21) cleared by the FDA?
Independent Corneal Viewing Chamber (IVC-21) (K211786) received a 510(k) decision of Substantially Equivalent on December 3, 2021, 177 days after the submission was received.
What is the product code of K211786?
The FDA product code is LYX – Media, Corneal Storage, a Unclassified device.