Product Code: MRC FDA class 2 21 CFR 886.5918

Products, Contact Lens Care, Rigid Gas Permeable

Ophthalmic

Rigid Gas Permeable Contact Lens Care Products are ophthalmic devices including solutions, cleaners, conditioners, and enzyme treatments designed for the cleaning, disinfection, rinsing, and storage of rigid gas permeable (RGP) contact lenses. Classified as FDA Class 2 under 21 CFR 886.5918, they require 510(k) premarket notification. The product code is MRC, and they are eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MRC in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MRC
Device Class: FDA class 2
Regulation Number: 886.5918
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251876	cleadew GP hydra one	Oct 09, 2025	Substantially Equivalent	Ophtecs Corporation
K200416	Boston One Step Liquid Enzymatic Cleaner	Sep 23, 2020	Substantially Equivalent	Bausch & Lomb, Incorporated
K201069	VibrantVue Scleral Saline	Jul 31, 2020	Substantially Equivalent	Dry Eye Innovations, LLC
K182984	MaxiTears Contacts PF	Jul 24, 2019	Substantially Equivalent	Omnivision AG
K181566	Nutrifill	Oct 22, 2018	Substantially Equivalent	Contamac, Ltd.
K181627	Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner	Aug 10, 2018	Substantially Equivalent	Bausch & Lomb, Incorporated
K180319	Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution	Mar 27, 2018	Substantially Equivalent	Bausch and Lomb, Incorporated
K173089	Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions	Nov 27, 2017	Substantially Equivalent	Bausch & Lomb, Incorporated
K173136	Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses	Nov 16, 2017	Substantially Equivalent	Menicon Co, Ltd.
K130805	MENICON UNIQUE PH MULTI-PURPOSE SOLUTION	Jul 03, 2013	Substantially Equivalent	Menicon Co, Ltd.
K122273	MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS	Jan 02, 2013	Substantially Equivalent	Menicon Co, Ltd.
K082855	MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES	Mar 09, 2010	Substantially Equivalent	Menicon Co, Ltd.
K052074	JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,	Sep 01, 2005	Substantially Equivalent	Szabocsik and Associates
K040839	COMPLETE BLINK-N-CLEAN LENS DROPS	Oct 19, 2004	Substantially Equivalent	Advanced Medical Optics, Inc.
K024289	BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION	May 02, 2003	Substantially Equivalent	Bausch & Lomb, Incorporated
K023455	AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION	Feb 28, 2003	Substantially Equivalent	Ciba Vision Corporation
K020930	MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES	May 02, 2002	Substantially Equivalent	Menicon Co, Ltd.
K013204	AQUIFY LENS COMFORT DROPS	Apr 03, 2002	Substantially Equivalent	Ciba Vision Corporation
K014162	MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND	Jan 15, 2002	Substantially Equivalent	Lobob Laboratories, Inc.
K011456	DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES	Jul 17, 2001	Substantially Equivalent	Sauflon Pharmaceuticals, Ltd.
K002140	MENICON PROGENT REMOVER	Oct 10, 2000	Substantially Equivalent	Menicon Co, Ltd.
K000975	LIPIDURE REWETTING DROPS	Sep 25, 2000	Substantially Equivalent	Nof Corp.
K001964	OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION	Jul 18, 2000	Substantially Equivalent	Lobob Laboratories, Inc.
K001235	OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136	Jul 03, 2000	Substantially Equivalent	Alcon Universal, Ltd.
K001428	OPTIMUM WETTING AND REWETTING DROP	May 26, 2000	Substantially Equivalent	Lobob Laboratories, Inc.
K000607	SOLO-CARE BRAND HARD SOLUTION	May 15, 2000	Substantially Equivalent	Ciba Vision Corporation
K000385	OPTI-FREE EXPRESS LENS DROPS	Apr 28, 2000	Substantially Equivalent	Alcon Universal, Ltd.
K000148	RGP MULTI-PURPOSE SOLUTION ID 100136	Apr 11, 2000	Substantially Equivalent	Alcon Laboratories
K994170	HYLASHIELD CL	Mar 02, 2000	Substantially Equivalent	Biomatrix, Inc.
K993949	SOLO-CARE BRAND HARD SOLUTION	Jan 05, 2000	Substantially Equivalent	Ciba Vision Corporation
K983836	RIGID GAS PERMEABLE CONTACT LENS SOLUTION	Feb 11, 1999	Substantially Equivalent	Polymer Technology Div. Wilmington Partners, L.P.
K983291	SOLO-CARE BRAND MULTI-PURPOSE SOLUTION	Nov 25, 1998	Substantially Equivalent	Ciba Vision Corporation
K974466	BOSTON ADVANCE CLEANER	Feb 19, 1998	Substantially Equivalent	Polymer Technology Corp.