FDA Product Code MRC: Products, Contact Lens Care, Rigid Gas Permeable
Leading manufacturers include Menicon Co, Ltd., Ciba Vision Corporation and Bausch & Lomb, Incorporated.
33
Total
33
Cleared
111d
Avg days
1998
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
113d avg (recent)
FDA 510(k) Cleared Products, Contact Lens Care, Rigid Gas Permeable Devices (Product Code MRC)
33 devices
Cleared
Oct 09, 2025
cleadew GP hydra one
Ophtecs Corporation
Ophthalmic
113d
Cleared
Sep 23, 2020
Boston One Step Liquid Enzymatic Cleaner
Bausch & Lomb, Incorporated
Ophthalmic
216d
Cleared
Jul 31, 2020
VibrantVue Scleral Saline
Dry Eye Innovations, LLC
Ophthalmic
100d
Cleared
Jul 24, 2019
MaxiTears Contacts PF
Omnivision AG
Ophthalmic
268d
Cleared
Oct 22, 2018
Nutrifill
Contamac, Ltd.
Ophthalmic
130d
Cleared
Aug 10, 2018
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
Bausch & Lomb, Incorporated
Ophthalmic
51d
Cleared
Mar 27, 2018
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
Bausch and Lomb, Incorporated
Ophthalmic
50d
Cleared
Nov 27, 2017
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
Bausch & Lomb, Incorporated
Ophthalmic
59d
Cleared
Nov 16, 2017
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Menicon Co, Ltd.
Ophthalmic
48d
Cleared
Jul 03, 2013
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
Menicon Co, Ltd.
Ophthalmic
100d
Cleared
Jan 02, 2013
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
Menicon Co, Ltd.
Ophthalmic
156d
Cleared
Mar 09, 2010
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
Menicon Co, Ltd.
Ophthalmic
526d
Cleared
Sep 01, 2005
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS
Szabocsik and Associates
Ophthalmic
31d
Cleared
Oct 19, 2004
COMPLETE BLINK-N-CLEAN LENS DROPS
Advanced Medical Optics, Inc.
Ophthalmic
202d
Cleared
May 02, 2003
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
Bausch & Lomb, Incorporated
Ophthalmic
130d
Cleared
Feb 28, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Ciba Vision Corporation
Ophthalmic
136d
Cleared
May 02, 2002
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
Menicon Co, Ltd.
Ophthalmic
41d
Cleared
Apr 03, 2002
AQUIFY LENS COMFORT DROPS
Ciba Vision Corporation
Ophthalmic
190d
Cleared
Jan 15, 2002
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
Lobob Laboratories, Inc.
Ophthalmic
27d
Cleared
Jul 17, 2001
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
Sauflon Pharmaceuticals, Ltd.
Ophthalmic
67d
Cleared
Oct 10, 2000
MENICON PROGENT REMOVER
Menicon Co, Ltd.
Ophthalmic
85d
Cleared
Sep 25, 2000
LIPIDURE REWETTING DROPS
Nof Corp.
Ophthalmic
182d
Cleared
Jul 18, 2000
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
Lobob Laboratories, Inc.
Ophthalmic
21d
Cleared
Jul 03, 2000
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
Alcon Universal, Ltd.
Ophthalmic
77d
About Product Code MRC - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code MRC since 1998, with 33 receiving FDA clearance (average review time: 111 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 - MRC Product Code
FDA review times for MRC submissions have been consistent, averaging 113 days recently vs 111 days historically.
MRC devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →