LYX

FDA Product Code LYX: Media, Corneal Storage

Leading manufacturers include Chiron Intraoptics, Bioclinical Laboratory Services, Inc. and Al.Chi.Mi.A.

21
Total
21
Cleared
120d
Avg days
1982
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 135d avg (recent)

FDA 510(k) Cleared Media, Corneal Storage Devices (Product Code LYX)

21 devices
1–21 of 21
Cleared Sep 11, 2025
XTRA4
K251320
Al.Chi.Mi.A. S.R.L
Ophthalmic · 135d
Cleared Oct 05, 2022
Cornisol
K221759
Aurolab
Ophthalmic · 110d
Cleared Dec 03, 2021
Independent Corneal Viewing Chamber (IVC-21)
K211786
Bausch & Lomb, Incorporated
Ophthalmic · 177d
Cleared Sep 15, 2016
Eusol-C
K162013
Al.Chi.Mi.A. S.R.L
Ophthalmic · 56d
Cleared Aug 06, 2015
Cornea Cold
K151061
Eurobio
Ophthalmic · 108d
Cleared Dec 21, 2007
LIFE4C
K063304
Numedis, Inc.
Ophthalmic · 415d
Cleared Feb 08, 2007
EUSOL-C
K063617
Al.Chi.Mi.A
Ophthalmic · 65d
Cleared Dec 15, 2003
EUSOL-C
K032422
Al.Chi.Mi.A
Ophthalmic · 132d
Cleared May 20, 1996
THE CHEN MEDIUM
K954548
Chen Ophthalmic Laboratories
Ophthalmic · 231d
Cleared Oct 06, 1992
OPTISOL-GS CORNEAL STORAGE MEDIA
K924165
Chiron Intraoptics
Ophthalmic · 48d
Cleared Jun 09, 1992
DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED
K921728
Chiron Intraoptics
Ophthalmic · 76d
Cleared Jun 09, 1992
OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED
K921729
Chiron Intraoptics
Ophthalmic · 76d
Cleared Jan 12, 1990
OPTISOL
K894162
Chiron Ophthalmics
Ophthalmic · 212d
Cleared Nov 16, 1988
DEXSOL
K883854
Northern Scientific, Inc.
Ophthalmic · 64d
Cleared Apr 06, 1987
MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
K870249
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Apr 06, 1987
MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
K870250
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Apr 06, 1987
CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM
K870251
Bioclinical Laboratory Services, Inc.
Ophthalmic · 75d
Cleared Sep 17, 1986
3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
K863129
3M Company
Ophthalmic · 33d
Cleared Dec 31, 1985
CSM MEDIUM
K854052
Northern Scientific, Inc.
Ophthalmic · 89d
Cleared Apr 30, 1985
K-SOL
K844249
Cilco, Inc.
Ophthalmic · 179d
Cleared Jul 14, 1982
CORNEA PERSERVATION UNIT
K821170
Xytex Corp.
Ophthalmic · 79d

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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LYX Product Code

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 →