Cornea Cold
FDA 510(k) K151061 · Eurobio
510(k) numberK151061
Submission
- Device name
- Cornea Cold
- Applicant
- Eurobio
Les Ulis, FR - Received
- April 20, 2015
- Decision date
- August 6, 2015
- 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
Other 510(k)s with product code LYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251320 | XTRA4LYX · Traditional | Al.Chi.Mi.A. S.R.L | 09/11/2025SE |
| K221759 | CornisolLYX · Traditional | Aurolab | 10/05/2022SE |
| K211786 | Independent Corneal Viewing Chamber (IVC-21)LYX · Traditional | Bausch + Lomb, Incorporated | 12/03/2021SE |
| K162013 | Eusol-CLYX · Special | Al.Chi.Mi.A. S.R.L | 09/15/2016SE |
| K063304 | LIFE4CLYX · Traditional | Numedis, Inc. | 12/21/2007SE |
| K063617 | Eusol-CLYX · Special | Al.Chi.Mi.A | 02/08/2007SE |
| K032422 | Eusol-CLYX · Traditional | Al.Chi.Mi.A | 12/15/2003SE |
| K954548 | The Chen MediumLYX · Traditional | Chen Ophthalmic Laboratories | 05/20/1996SE |
| K924165 | Optisol-Gs Corneal Storage MediaLYX · Traditional | Chiron Intraoptics | 10/06/1992SE |
| K921729 | Optisol Corneal Storage Media Container/ModifiedLYX · Traditional | Chiron Intraoptics | 06/09/1992SE |
Questions and answers
When was Cornea Cold cleared by the FDA?
Cornea Cold (K151061) received a 510(k) decision of Substantially Equivalent on August 6, 2015, 108 days after the submission was received.
What is the product code of K151061?
The FDA product code is LYX – Media, Corneal Storage, a Unclassified device.