Cornisol
FDA 510(k) clearance K221759 · decided 2022-10-05
Clearance details
- K-number
- K221759
- Device name
- Cornisol
- Applicant
- Aurolab
- Decision
- Substantially Equivalent
- Date received
- 2022-06-17
- Decision date
- 2022-10-05
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- LYX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Veerapanjan, Madurai, IN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XTRA4 (K251320) | Al.Chi.Mi.A. S.R.L | 2025-09-11 |
| Independent Corneal Viewing Chamber (IVC-21) (K211786) | Bausch + Lomb, Incorporated | 2021-12-03 |
| Eusol-C (K162013) | Al.Chi.Mi.A. S.R.L | 2016-09-15 |
| Cornea Cold (K151061) | Eurobio | 2015-08-06 |
| LIFE4C (K063304) | Numedis, Inc. | 2007-12-21 |
| EUSOL-C (K063617) | Al.Chi.Mi.A | 2007-02-08 |
| 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.