510(k) K211786
K211786 is an FDA 510(k) premarket notification submitted by Bausch + Lomb, Incorporated for the device "Independent Corneal Viewing Chamber (IVC-21)". The FDA issued a decision of Substantially Equivalent on December 3, 2021. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Bausch + Lomb, Incorporated has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2021
- Date Received
- June 9, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Corneal Storage
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type