Media, Corneal Storage
The Corneal Storage Media (product code LYX) is an ophthalmic solution used to preserve and store donor corneal tissue prior to transplantation, maintaining corneal viability and endothelial cell function during the storage period. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Ophthalmic (OP) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- LYX
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251320 | XTRA4 | Sep 11, 2025 | Substantially Equivalent | Al.Chi.Mi.A. S.R.L |
| K221759 | Cornisol | Oct 05, 2022 | Substantially Equivalent | Aurolab |
| K211786 | Independent Corneal Viewing Chamber (IVC-21) | Dec 03, 2021 | Substantially Equivalent | Bausch + Lomb, Incorporated |
| K162013 | Eusol-C | Sep 15, 2016 | Substantially Equivalent | Al.Chi.Mi.A. S.R.L |
| K151061 | Cornea Cold | Aug 06, 2015 | Substantially Equivalent | Eurobio |
| K063304 | LIFE4C | Dec 21, 2007 | Substantially Equivalent | Numedis, Inc. |
| K063617 | EUSOL-C | Feb 08, 2007 | Substantially Equivalent | Al.Chi.Mi.A |
| K032422 | EUSOL-C | Dec 15, 2003 | Substantially Equivalent | Al.Chi.Mi.A |
| K954548 | THE CHEN MEDIUM | May 20, 1996 | Substantially Equivalent | Chen Ophthalmic Laboratories |
| K924165 | OPTISOL-GS CORNEAL STORAGE MEDIA | Oct 06, 1992 | Substantially Equivalent | Chiron Intraoptics |
| K921729 | OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED | Jun 09, 1992 | Substantially Equivalent | Chiron Intraoptics |
| K921728 | DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED | Jun 09, 1992 | Substantially Equivalent | Chiron Intraoptics |
| K894162 | OPTISOL | Jan 12, 1990 | Substantially Equivalent | Chiron Ophthalmics |
| K883854 | DEXSOL | Nov 16, 1988 | Substantially Equivalent | Northern Scientific, Inc. |
| K870251 | CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM | Apr 06, 1987 | Substantially Equivalent | Bioclinical Laboratory Services, Inc. |
| K870250 | MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | Apr 06, 1987 | Substantially Equivalent | Bioclinical Laboratory Services, Inc. |
| K870249 | MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | Apr 06, 1987 | Substantially Equivalent | Bioclinical Laboratory Services, Inc. |
| K863129 | 3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM) | Sep 17, 1986 | Substantially Equivalent | 3M Company |
| K854052 | CSM MEDIUM | Dec 31, 1985 | Substantially Equivalent | Northern Scientific, Inc. |
| K844249 | K-SOL | Apr 30, 1985 | Substantially Equivalent | Cilco, Inc. |
| K821170 | CORNEA PERSERVATION UNIT | Jul 14, 1982 | Substantially Equivalent | Xytex Corp. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.