MRC · Products, Contact Lens Care, Rigid Gas Permeable
Ophthalmic · 21 CFR 886.5918 · Class 2
Overview
| Product Code | MRC |
|---|---|
| Device Name | Products, Contact Lens Care, Rigid Gas Permeable |
| Regulation | 21 CFR 886.5918 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 | cleadew GP hydra one | Ophtecs Corporation | Oct 9, 2025 | SESE |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | Sep 23, 2020 | SESE |
| K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | Jul 31, 2020 | SESE |
| K182984 | MaxiTears Contacts PF | Omnivision AG | Jul 24, 2019 | SESE |
| K181566 | Nutrifill | Contamac, Ltd. | Oct 22, 2018 | SESE |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | Aug 10, 2018 | SESE |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | Bausch and Lomb, Incorporated | Mar 27, 2018 | SESE |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | Bausch & Lomb, Incorporated | Nov 27, 2017 | SESE |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | Nov 16, 2017 | SESE |
| K130805 | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION | Menicon Co, Ltd. | Jul 3, 2013 | SESE |
| K122273 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | Jan 2, 2013 | SESE |
| K082855 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | Mar 9, 2010 | SESE |
| K052074 | 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 | COMPLETE BLINK-N-CLEAN LENS DROPS | Advanced Medical Optics, Inc. | Oct 19, 2004 | SESE |
| K024289 | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | Bausch & Lomb, Incorporated | May 2, 2003 | SESE |
| K023455 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Feb 28, 2003 | SESE |
| K020930 | MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | May 2, 2002 | SESE |
| K013204 | AQUIFY LENS COMFORT DROPS | Ciba Vision Corporation | Apr 3, 2002 | SESE |
| K014162 | MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND | Lobob Laboratories, Inc. | Jan 15, 2002 | SESE |
| K011456 | 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
