FDA Product Code LYX: Media, Corneal Storage
Leading manufacturers include Bausch & Lomb, Incorporated and Al.Chi.Mi.A. S.R.L.
21
Total
21
Cleared
120d
Avg days
1982
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
135d avg (recent)
FDA 510(k) Cleared Media, Corneal Storage Devices (Product Code LYX)
21 devices
Cleared
Sep 11, 2025
XTRA4
Al.Chi.Mi.A. S.R.L
Ophthalmic
135d
Cleared
Dec 03, 2021
Independent Corneal Viewing Chamber (IVC-21)
Bausch & Lomb, Incorporated
Ophthalmic
177d
About Product Code LYX - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code LYX since 1982, with 21 receiving FDA clearance (average review time: 120 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for LYX submissions have been consistent, averaging 135 days recently vs 119 days historically.
LYX devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →