Independent Corneal Viewing Chamber (IVC-21)
FDA 510(k) clearance K211786 · decided 2021-12-03
Clearance details
- K-number
- K211786
- Device name
- Independent Corneal Viewing Chamber (IVC-21)
- Applicant
- Bausch + Lomb, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2021-06-09
- Decision date
- 2021-12-03
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- LYX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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| EUSOL-C (K032422) | Al.Chi.Mi.A | 2003-12-15 |
| THE CHEN MEDIUM (K954548) | Chen Ophthalmic Laboratories | 1996-05-20 |
| OPTISOL-GS CORNEAL STORAGE MEDIA (K924165) | Chiron Intraoptics | 1992-10-06 |
| OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (K921729) | Chiron Intraoptics | 1992-06-09 |
| DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (K921728) | Chiron Intraoptics | 1992-06-09 |
| OPTISOL (K894162) | Chiron Ophthalmics | 1990-01-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080021) | Bausch & Lomb, Incorporated | 2009-02-02 |