FDA product code LYX: Media, Corneal Storage
LYX is the FDA product code for media, corneal storage. It is a Unclassified device, reviewed by the Ophthalmic panel. FDA has cleared 21 510(k) submissions under LYX, 2 in the last five years, from 14 different applicants. The average 510(k) review took 120 days (median 79); 135 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Media, Corneal Storage |
| Device class | Unclassified |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LYX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 177 |
| 2022 | 1 | 110 |
| 2025 | 1 | 135 |
Compare with all 510(k) review times · Search every LYX clearance
Top LYX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chiron Intraoptics | 3 | 1992-10-06 |
| Bioclinical Laboratory Services, Inc. | 3 | 1987-04-06 |
| Al.Chi.Mi.A. S.R.L | 2 | 2025-09-11 |
| Al.Chi.Mi.A | 2 | 2007-02-08 |
| Northern Scientific, Inc. | 2 | 1988-11-16 |
9 more applicants have LYX clearances. See the full list in Caduvo.
Most recent LYX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251320 | Al.Chi.Mi.A. S.R.L | XTRA4 | 2025-09-11 | 135 |
| K221759 | Aurolab | Cornisol | 2022-10-05 | 110 |
| K211786 | Bausch + Lomb, Incorporated | Independent Corneal Viewing Chamber (IVC-21) | 2021-12-03 | 177 |
| K162013 | Al.Chi.Mi.A. S.R.L | Eusol-C | 2016-09-15 | 56 |
| K151061 | Eurobio | Cornea Cold | 2015-08-06 | 108 |
Recalls for LYX devices
openFDA lists no recalls for product code LYX.
Frequently asked questions
What is FDA product code LYX?
LYX is the FDA product code for media, corneal storage. It is a Unclassified device, reviewed by the Ophthalmic panel.
What device class is LYX?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYX?
Across 21 cleared submissions the average was 120 days from receipt to decision (median 79).
Which companies have the most LYX clearances?
Chiron Intraoptics (3); Bioclinical Laboratory Services, Inc. (3); Al.Chi.Mi.A. S.R.L (2); Al.Chi.Mi.A (2); Northern Scientific, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LYX
- Run a recall and safety report across every LYX manufacturer
- Watch product code LYX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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