Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5918](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5918) → MRC — Products, Contact Lens Care, Rigid Gas Permeable # MRC · Products, Contact Lens Care, Rigid Gas Permeable _Ophthalmic · 21 CFR 886.5918 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC ## Overview - **Product Code:** MRC - **Device Name:** Products, Contact Lens Care, Rigid Gas Permeable - **Regulation:** [21 CFR 886.5918](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5918) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses. ## Classification Rationale Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Special Controls *Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Recent Cleared Devices (20 of 33) Showing 20 most recent of 33 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251876](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K251876.md) | cleadew GP hydra one | Ophtecs Corporation | Oct 9, 2025 | SESE | | [K200416](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K200416.md) | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | Sep 23, 2020 | SESE | | [K201069](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K201069.md) | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | Jul 31, 2020 | SESE | | [K182984](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K182984.md) | MaxiTears Contacts PF | Omnivision AG | Jul 24, 2019 | SESE | | [K181566](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K181566.md) | Nutrifill | Contamac, Ltd. | Oct 22, 2018 | SESE | | [K181627](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K181627.md) | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | Aug 10, 2018 | SESE | | [K180319](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K180319.md) | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | Bausch and Lomb, Incorporated | Mar 27, 2018 | SESE | | [K173089](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K173089.md) | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | Bausch & Lomb, Incorporated | Nov 27, 2017 | SESE | | [K173136](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K173136.md) | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | Nov 16, 2017 | SESE | | [K130805](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K130805.md) | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION | Menicon Co, Ltd. | Jul 3, 2013 | SESE | | [K122273](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K122273.md) | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | Jan 2, 2013 | SESE | | [K082855](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K082855.md) | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | Mar 9, 2010 | SESE | | [K052074](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K052074.md) | JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, | Szabocsik and Associates | Sep 1, 2005 | SESE | | [K040839](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K040839.md) | COMPLETE BLINK-N-CLEAN LENS DROPS | Advanced Medical Optics, Inc. | Oct 19, 2004 | SESE | | [K024289](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K024289.md) | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | Bausch & Lomb, Incorporated | May 2, 2003 | SESE | | [K023455](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K023455.md) | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Feb 28, 2003 | SESE | | [K020930](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K020930.md) | MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | May 2, 2002 | SESE | | [K013204](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K013204.md) | AQUIFY LENS COMFORT DROPS | Ciba Vision Corporation | Apr 3, 2002 | SESE | | [K014162](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K014162.md) | MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND | Lobob Laboratories, Inc. | Jan 15, 2002 | SESE | | [K011456](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K011456.md) | DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | Jul 17, 2001 | SESE | ## Top Applicants - Menicon Co, Ltd. — 6 clearances - Ciba Vision Corporation — 5 clearances - Bausch & Lomb, Incorporated — 4 clearances - Lobob Laboratories, Inc. — 3 clearances - Alcon Universal, Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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