Product code MRC
- Device name
- Products, Contact Lens Care, Rigid Gas Permeable
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5918
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251876 | cleadew GP hydra one | Ophtecs Corporation | 2025-10-09 |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | 2020-09-23 |
| K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | 2020-07-31 |
| K182984 | MaxiTears Contacts PF | Omnivision AG | 2019-07-24 |
| K181566 | Nutrifill | Contamac, Ltd. | 2018-10-22 |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | 2018-08-10 |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | Bausch and Lomb, Incorporated | 2018-03-27 |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | Bausch & Lomb, Incorporated | 2017-11-27 |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | 2017-11-16 |
| K130805 | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION | Menicon Co, Ltd. | 2013-07-03 |
| K122273 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | 2013-01-02 |
| K082855 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | 2010-03-09 |
| K052074 | JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, | Szabocsik and Associates | 2005-09-01 |
| K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | Advanced Medical Optics, Inc. | 2004-10-19 |
| K024289 | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | Bausch & Lomb, Incorporated | 2003-05-02 |
| K023455 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | 2003-02-28 |
| K020930 | MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | 2002-05-02 |
| K013204 | AQUIFY LENS COMFORT DROPS | Ciba Vision Corporation | 2002-04-03 |
| K014162 | MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND | Lobob Laboratories, Inc. | 2002-01-15 |
| K011456 | DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | 2001-07-17 |
| K002140 | MENICON PROGENT REMOVER | Menicon Co, Ltd. | 2000-10-10 |
| K000975 | LIPIDURE REWETTING DROPS | Nof Corp. | 2000-09-25 |
| K001964 | OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION | Lobob Laboratories, Inc. | 2000-07-18 |
| K001235 | OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 | Alcon Universal, Ltd. | 2000-07-03 |
| K001428 | OPTIMUM WETTING AND REWETTING DROP | Lobob Laboratories, Inc. | 2000-05-26 |
| K000607 | SOLO-CARE BRAND HARD SOLUTION | Ciba Vision Corporation | 2000-05-15 |
| K000385 | OPTI-FREE EXPRESS LENS DROPS | Alcon Universal, Ltd. | 2000-04-28 |
| K000148 | RGP MULTI-PURPOSE SOLUTION ID 100136 | Alcon Laboratories | 2000-04-11 |
| K994170 | HYLASHIELD CL | Biomatrix, Inc. | 2000-03-02 |
| K993949 | SOLO-CARE BRAND HARD SOLUTION | Ciba Vision Corporation | 2000-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04950055206512 | cleadew GP hydra one | OPHTECS CORPORATION | 2026-05-11 |
| 04950055206505 | cleadew GP hydra one | OPHTECS CORPORATION | 2026-05-11 |
| 00095072096006 | Up&Up | TARGET CORPORATION | 2026-04-22 |
| 00198168143803 | Tangible Fill | DRY EYE INNOVATIONS, LLC | 2026-04-22 |
| 00850013056095 | VibrantVue | DRY EYE INNOVATIONS, LLC | 2025-12-01 |
| 00850013056071 | VibrantVue | DRY EYE INNOVATIONS, LLC | 2025-12-01 |
| 00196527447258 | Zenlens Patient Kit | Bausch & Lomb Incorporated | 2025-06-17 |
| 00713733766173 | Meijer | MEIJER, INC. | 2024-10-23 |
| 00713733766197 | Meijer | MEIJER, INC. | 2024-10-23 |
| 00198168983577 | Tangible Clean | TANGIBLE SCIENCE, INC. | 2024-04-22 |
| 00198168596739 | Tangible Clean Sample Bottle | TANGIBLE SCIENCE, INC. | 2024-04-22 |
| 00860005853410 | Aqua Naina Sterile Saline Solution | Chemtex USA Inc. | 2024-03-20 |
| 00310119022771 | Biotrue® Hydration Boost Contact Lens Rehydrating Drops | Bausch & Lomb Incorporated | 2023-10-25 |
| 00310119303696 | ScleralFil | Bausch & Lomb Incorporated | 2023-07-05 |
| 00364108422301 | LensGiene | OPTICS LABORATORY, INC. | 2023-05-05 |
| 00310119022498 | Biotrue® Hydration Boost Contact Lens Rehydrating Drops | Bausch & Lomb Incorporated | 2023-04-27 |
| 00830002000018 | PuriLens Plus Preservative Free Saline | LIFESTYLE CO INC, THE | 2021-09-24 |
| 00681131179119 | Equate | WAL-MART STORES, INC. | 2020-11-17 |
| 00681131179126 | Equate | WAL-MART STORES, INC. | 2020-11-17 |
| 00681131176361 | Equate | WAL-MART STORES, INC. | 2020-11-17 |
| 00310119303818 | up & up rigid gas permeable contact lens conditioning solution | TARGET CORPORATION | 2020-06-05 |
| 00310119054536 | Bausch + Lomb | Bausch & Lomb Incorporated | 2020-05-28 |
| 00310119054543 | Bausch + Lomb | Bausch & Lomb Incorporated | 2020-05-28 |
| 00310119054550 | Bausch + Lomb | Bausch & Lomb Incorporated | 2020-05-28 |
| 00047113709338 | CLEAR CARE | Alcon Laboratories, Inc. | 2020-02-25 |
| 00047144051239 | Bausch + Lomb | Bausch & Lomb Incorporated | 2018-12-18 |
| 00047144073385 | Bausch + Lomb | Bausch & Lomb Incorporated | 2018-12-18 |
| 00047144074207 | Bausch + Lomb | Bausch & Lomb Incorporated | 2018-12-18 |
| 00047144074696 | Bausch + Lomb | Bausch & Lomb Incorporated | 2018-12-18 |
| 00047144055091 | Bausch + Lomb | Bausch & Lomb Incorporated | 2018-12-17 |