Product code LPN
- Device name
- Accessories, Soft Lens Products
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5928
- 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 PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P870051S007 | SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE) | Trp Company | 1997-10-15 |
| P870050S007 | SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE) | Trp Company | 1997-10-15 |
| P910074S001 | CONTACLAIR MULTI-PURPOSE SOLUTION | Eureka Laboratories, Inc. | 1997-07-03 |
| P860023S012 | BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | 1997-07-03 |
| P850088S036 | ULTRA CARE (TM) NEUTRALIZING TABLET | Advanced Medical Optics, Inc. | 1997-07-03 |
| P820001S023 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | Alcon Laboratories | 1997-07-03 |
| P850076S009 | SORBIC ACID PRESERVED DAILY CLEANER | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| P850075S009 | SORBIC ACID PRESERVED LENS LUBRICANT | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| P850070S010 | STERILE SALINE PRESERVED SOLUTION | Automatic Liquid Packaging, Inc. | 1997-07-02 |
| P840069S007 | CHARTER LABS SALINE SOLUTION | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| P830034S034 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 81573 | Alcon Laboratories | 1997-07-02 |
| P820001S022 | OPTI-FREE SUPRACLENS | Alcon Laboratories | 1997-07-02 |
| P850070S009 | STERILE SALINE PRESERVED SOLUTION | Automatic Liquid Packaging, Inc. | 1997-06-20 |
| P870051S006 | SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE) | Trp Company | 1997-06-02 |
| P870050S006 | SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE) | Trp Company | 1997-06-02 |
| P830071S008 | ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392 | Alcon Laboratories | 1997-05-15 |
| P820001S021 | OPTI-ZYME ENZYMATIC CLEANER | Alcon Laboratories | 1997-05-15 |
| P960012S001 | REFRESH CL(TM)/LUBRICATING AND REWETING DROPS | Abbott Medical Optics, Inc. | 1997-04-24 |
| P830034S031 | OPTI-FREE REWETTING DROPS | Alcon Laboratories | 1997-03-26 |
| P830071S009 | OPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392 | Alcon Laboratories | 1997-03-19 |
| P830034S033 | OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION | Alcon Laboratories | 1997-03-19 |
| P820031S014 | SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION | Bausch & Lomb, Inc. | 1997-03-10 |
| P820053S025 | COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION | Advanced Medical Optics, Inc. | 1997-02-13 |
| P830071S007 | OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392 | Alcon Laboratories | 1997-02-10 |
| P830034S030 | ALCON MULTI-PURPOSE SOLUTION ID 81573 | Alcon Laboratories | 1997-02-10 |
| P820001S020 | OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER | Alcon Laboratories | 1997-02-10 |
| N18143S033 | FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION | Alcon Laboratories | 1997-02-10 |
| N17908S047 | ALCON SALINE SOLUTION | Alcon Laboratories | 1997-02-10 |
| P840066S034 | USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION | Advanced Medical Optics, Inc. | 1997-01-23 |
| P830034S029 | OPTI-ONE(R) MULTI-PURPOSE SOLUTION | Alcon Laboratories | 1996-11-21 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | Bausch & Lomb, Incorporated | 2022-12-06 |
| K221263 | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | 2022-10-12 |
| K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | 2021-05-28 |
| K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | 2021-05-26 |
| K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | 2020-05-26 |
| K200747 | PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. | 2020-05-15 |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | 2020-03-02 |
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | 2019-08-08 |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2019-07-31 |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017-04-11 |
| K161819 | NNR06 Multi-Purpose Solution | Bausch & Lomb, Incorporated | 2016-11-25 |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2016-10-19 |
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | 2016-08-11 |
| K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015-08-28 |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | Alcon Laboratories, Inc. | 2015-01-26 |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | Bausch & Lomb, Incorporated | 2013-09-09 |
| K130734 | SAUFLON MULTIPURPOSE SOLUTION | Sauflon Pharmaceuticals, Ltd. | 2013-05-15 |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | Bausch & Lomb, Inc. | 2012-04-30 |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | Bausch & Lomb, Inc. | 2012-01-24 |
| K110221 | EYE-CEPT STERILE SALINE SOLUTION | Optics Laboratory, Inc. | 2011-11-01 |
| K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | 2011-05-10 |
| K102165 | STERILE SALINE SOLUTION | Cachet Pharmaceuticals Pvt. , Ltd. | 2011-01-19 |
| K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | Abbott Medical Optics, Inc. | 2010-09-15 |
| K093367 | STERILE SALINE SOLUTION | Cachet Pharmaceuticals Pvt. , Ltd. | 2010-09-10 |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | Allergan, Inc. | 2009-07-09 |
| K071236 | ALCON MULTI-PURPOSE SOLUTION | Alcon, Inc. | 2007-12-12 |
| K070767 | EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION | Lapis Lazuli International NV | 2007-07-24 |
| K071203 | SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES | Optikem International, Inc. | 2007-06-13 |
| K062332 | ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION | Altaire Pharmaceuticals, Inc. | 2007-04-25 |
| K060924 | JSZ MULTIACTION GP CONTACT LENS SOLUTION | Szabocsik and Associates | 2006-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00310119303696 | ScleralFil | Bausch & Lomb Incorporated | 2023-07-05 |
| 00194346058792 | EQUATE | WAL-MART STORES, INC. | 2023-01-18 |
| 00194346058785 | EQUATE | WAL-MART STORES, INC. | 2023-01-18 |
| 00311917012025 | Walgreens | WALGREEN CO. | 2022-05-24 |
| 00311917011950 | Walgreens | WALGREEN CO. | 2022-05-24 |
| 00681131731904 | Equate | WAL-MART STORES, INC. | 2020-11-17 |
| 00681131731898 | Equate | WAL-MART STORES, INC. | 2020-11-17 |
| 00681131102155 | Equate | WAL-MART STORES, INC. | 2020-11-17 |
| 00681131025386 | Equate | WAL-MART STORES, INC. | 2020-11-17 |
| 00095072202018 | UP & UP | TARGET CORPORATION | 2020-11-09 |
| 00095072202025 | UP & UP | TARGET CORPORATION | 2020-11-09 |
| 00310119300497 | up & up multi-purpose solution | TARGET CORPORATION | 2020-06-05 |
| 00310119300602 | up & up saline solution | TARGET CORPORATION | 2020-06-05 |
| 00310119300480 | up & up multi-purpose solution | TARGET CORPORATION | 2020-06-05 |
| 00310119300473 | up & up multi-purpose solution | TARGET CORPORATION | 2020-06-05 |
| 00300653610060 | ALCON | Alcon Laboratories, Inc. | 2020-02-26 |
| 00096295137132 | LEADER | Cardinal Health 110, Inc. | 2019-08-29 |
| 00096295137088 | LEADER | Cardinal Health 110, Inc. | 2019-08-29 |
| 00050428572207 | REVITALENS | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2017-04-10 |
| 00050428568828 | BLINK-N-CLEAN | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2017-04-10 |
| 00078742168739 | MEMBERS MARK | WAL-MART STORES, INC. | 2016-11-25 |
| 00022600017172 | Simply Saline® Contact Lenses Sterile Saline Solution | CHURCH & DWIGHT CO., INC. | 2016-10-14 |
| 00041415069763 | Publix Comfort Formula Multi-purpose Disinfecting Solution | PUBLIX SUPER MARKETS, INC. | 2016-09-27 |
| 00041415015760 | Publix Sterile No Rub Multi-purpose Solution | PUBLIX SUPER MARKETS, INC. | 2016-09-27 |
| 00300650193207 | OPTI-FREE EXPRESS | Alcon Laboratories, Inc. | 2016-09-24 |
| 00300650193108 | OPTI-FREE EXPRESS | Alcon Laboratories, Inc. | 2016-09-24 |
| 00321130788027 | SIGNATURE | BETTER LIVING BRANDS LLC | 2016-09-20 |
| 00041163472549 | EQUALINE | SUPERVALU INC. | 2016-09-20 |
| 00678112653218 | Clear Eyes® | Medtech Products Inc. | 2016-09-16 |
| 00078742092751 | MEMBERS MARK | WAL-MART STORES, INC. | 2016-09-09 |