LPN · Accessories, Soft Lens Products
Ophthalmic · 21 CFR 886.5928 · Class 2
Overview
| Product Code | LPN |
|---|---|
| Device Name | Accessories, Soft Lens Products |
| Regulation | 21 CFR 886.5928 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
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.”
Cleared Devices (122)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | Bausch & Lomb, Incorporated | Dec 6, 2022 | SESE |
| K221263 | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | Oct 12, 2022 | SESE |
| K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | May 28, 2021 | SESE |
| K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | May 26, 2021 | SESE |
| K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | May 26, 2020 | SESE |
| K200747 | PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. | May 15, 2020 | SESE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | Mar 2, 2020 | SESE |
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | Aug 8, 2019 | SESE |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Jul 31, 2019 | SESE |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | Apr 11, 2017 | SESE |
| K161819 | NNR06 Multi-Purpose Solution | Bausch & Lomb, Incorporated | Nov 25, 2016 | SESE |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Oct 19, 2016 | SESE |
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | Aug 11, 2016 | SESE |
| K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | Aug 28, 2015 | SESE |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | Alcon Laboratories, Inc. | Jan 26, 2015 | SESE |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | Bausch & Lomb, Incorporated | Sep 9, 2013 | SESE |
| K130734 | SAUFLON MULTIPURPOSE SOLUTION | Sauflon Pharmaceuticals, Ltd. | May 15, 2013 | SESE |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | Bausch & Lomb, Inc. | Apr 30, 2012 | SESE |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | Bausch & Lomb, Inc. | Jan 24, 2012 | SESE |
| K110221 | EYE-CEPT STERILE SALINE SOLUTION | Optics Laboratory, Inc. | Nov 1, 2011 | SESE |
| K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | May 10, 2011 | SESE |
| K102165 | STERILE SALINE SOLUTION | Cachet Pharmaceuticals Pvt. , Ltd. | Jan 19, 2011 | SESE |
| K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | Abbott Medical Optics, Inc. | Sep 15, 2010 | SESE |
| K093367 | STERILE SALINE SOLUTION | Cachet Pharmaceuticals Pvt. , Ltd. | Sep 10, 2010 | SESE |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | Allergan, Inc. | Jul 9, 2009 | SESE |
| K071236 | ALCON MULTI-PURPOSE SOLUTION | Alcon, Inc. | Dec 12, 2007 | SESE |
| K070767 | EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION | Lapis Lazuli International NV | Jul 24, 2007 | SESE |
| K071203 | SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES | Optikem International, Inc. | Jun 13, 2007 | SESE |
| K062332 | ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION | Altaire Pharmaceuticals, Inc. | Apr 25, 2007 | SESE |
| K060924 | JSZ MULTIACTION GP CONTACT LENS SOLUTION | Szabocsik and Associates | Jun 28, 2006 | SESE |
| K051104 | EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION | Lapis Lazuli, NV | May 31, 2006 | SESE |
| K050729 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | Sep 14, 2005 | SESE |
| K050250 | AQUIFY MULTIPURPOSE SOLUTION | Ciba Vision Corporation | Aug 10, 2005 | SESE |
| K042562 | LENS PLUS REWETTING DROPS | Advanced Medical Optics, Inc. | Jul 29, 2005 | SESE |
| K041008 | EYE-CEPT REWETTING DROPS | Optics Laboratory, Inc. | Jul 1, 2005 | SESE |
| K050517 | JSZ-MULTIPURPOSE SOLUTION | Szabocsik and Associates | Apr 13, 2005 | SESE |
| K042176 | AQUIFY LENS COMFORT DROPS | Ciba Vision Corporation | Nov 3, 2004 | SESE |
| K031753 | KARATS MULTIPURPOSE SOLUTION | Ciba Vision Corporation | Oct 28, 2004 | SESE |
| K033608 | AQUIFY MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | Feb 2, 2004 | SESE |
| K031646 | BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 | Bausch & Lomb, Inc. | Nov 14, 2003 | SESE |
| K032481 | THERATEARS CONTACT LENS COMFORT DROPS | Advanced Vision Research, Inc. | Nov 4, 2003 | SESE |
| K030910 | CLUED UP MULTIPURPOSE SOLUTION- NO RUB | Clued UP Limited | Oct 10, 2003 | SESE |
| K032030 | BLINK CL LUBRICANT EYE DROPS | Advanced Medical Optics, Inc. | Sep 25, 2003 | SESE |
| K030522 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Sep 12, 2003 | SESE |
| K031957 | MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | Aug 14, 2003 | SESE |
| K030278 | SAUFLON MULTIPURPOSE SOLUTION - NO RUB | Sauflon Pharmaceuticals, Ltd. | Jul 30, 2003 | SESE |
| K031193 | SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION | Alcon, Inc. | Jul 3, 2003 | SESE |
| K031522 | SOLO-CARE PLUS MULTIPURPOSE SOLUTION | Ciba Vision Corporation | Jun 27, 2003 | SESE |
| K031521 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Jun 27, 2003 | SESE |
| K030092 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Advanced Medical Optics, Inc. | Apr 4, 2003 | SESE |
| K021635 | KARATS MULTIPURPOSE SOLUTION | Ciba Vision Corporation | Oct 28, 2002 | SESE |
| K021143 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | Aug 8, 2002 | SESE |
| K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | Feb 20, 2002 | SESE |
| K013479 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | Feb 11, 2002 | SESE |
| K012731 | SOLO-CARE PLUS MULTIPURPOSE SOLUTION | Ciba Vision Corporation | Dec 26, 2001 | SESE |
| K013512 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Dec 20, 2001 | SESE |
| K010559 | SAUFLON MULTI LENS CARE SYSTEM | Sauflon Pharmaceuticals, Ltd. | Dec 20, 2001 | SESE |
| K011561 | SEREINE EXTRA STRENGTH DAILY CLEANER | Wilsa, Inc. | Nov 20, 2001 | SESE |
| K011796 | RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | Nov 1, 2001 | SESE |
| K003345 | AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Mar 26, 2001 | SESE |
| K003252 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | Feb 21, 2001 | SESE |
| K003031 | LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML | Alpha Vista, Inc. | Jan 5, 2001 | SESE |
| K003109 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | Nov 21, 2000 | SESE |
| K002589 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | Oct 23, 2000 | SESE |
| K002823 | RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION | Bausch & Lomb, Inc. | Oct 17, 2000 | SESE |
| K002319 | PURILENS SALINE SOLUTION | Purilens, Inc. | Aug 30, 2000 | SESE |
| K001539 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | Jul 31, 2000 | SESE |
| K001214 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | Jul 10, 2000 | SESE |
| K000998 | OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES | Optisonic, Inc. | Jun 5, 2000 | SESE |
| K000164 | COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION | Allergan, Inc. | Jun 2, 2000 | SESE |
| K000247 | BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER | Bausch & Lomb, Inc. | Apr 20, 2000 | SESE |
| K992028 | REFRESH CONTACTS LUBRICATING AND REWETTING DROPS | Allergan, Inc. | Oct 7, 1999 | SESE |
| K991620 | VISINE FOR CONTACTS | Pfizer, Inc. | Sep 24, 1999 | SESE |
| K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP | Alcon Laboratories | Sep 16, 1999 | SESE |
| K991125 | SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | Sep 14, 1999 | SESE |
| K991403 | SOLO-CARE BRAND MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | Jul 16, 1999 | SESE |
| K990480 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | Alcon Laboratories | May 10, 1999 | SESE |
| K990422 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | Apr 27, 1999 | SESE |
| K983225 | BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER | Bausch & Lomb, Inc. | Mar 29, 1999 | SESE |
| K990044 | LOBOB UNIVERSAL CONTACT LENS CLEANER | Lobob Laboratories, Inc. | Feb 11, 1999 | SESE |
| K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Alcon Laboratories | Jan 14, 1999 | SESE |
| K984383 | ULTRACARE NEUTRALIZING TABLETS | Allergan, Inc. | Dec 18, 1998 | SESE |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Alcon Laboratories | Dec 18, 1998 | SESE |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Alcon Laboratories | Dec 18, 1998 | SESE |
| K983150 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | Nov 25, 1998 | SESE |
| K982168 | SOLO-CARE BRAND MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | Nov 17, 1998 | SESE |
| K982775 | BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | Nov 3, 1998 | SESE |
| K981168 | COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | Sep 1, 1998 | SESE |
| K981561 | LIQUID ENZYME ID 90133 | Alcon Laboratories | Jul 24, 1998 | SESE |
| K981574 | OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION | Alcon | Jul 6, 1998 | SESE |
| K980775 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | Jul 6, 1998 | SESE |
| K980591 | RENU MULTIPLUS LUBRICATING & REWETTING DROPS | Bausch & Lomb, Inc. | Jun 24, 1998 | SESE |
| K981151 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392 | Alcon Laboratories | Jun 22, 1998 | SESE |
| K980147 | YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION | Automatic Liquid Packaging, Inc. | Apr 13, 1998 | SESE |
| K980133 | BAUSCH & LOMB WETTING AND SOAKING SOLUTION | Polymer Technology Corp. | Mar 11, 1998 | SESE |
| K974723 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | Mar 10, 1998 | SESE |
| K974625 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | Alcon Laboratories | Mar 4, 1998 | SESE |
| K974624 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Alcon Laboratories | Mar 4, 1998 | SESE |
| K974485 | SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION | Szabocsik and Assoc. | Feb 24, 1998 | SESE |
| K973921 | BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | Jan 12, 1998 | SESE |
| K973332 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Alcon Laboratories | Dec 2, 1997 | SESE |
| K973217 | BOSTON LIQUID ENZYMATIC CLEANER | Polymer Technology Corp. | Nov 24, 1997 | SESE |
| K923438 | BOSTON CONDITIONING SOLUTION | Polymer Technology Corp. | Dec 28, 1992 | SESE |
| K923437 | BOSTON CLEANER II | Polymer Technology Corp. | Oct 28, 1992 | SESE |
| K914483 | WETTING SOLUTION FOR HARD CONTACT LENSES | Optopics Laboratories Corp. | Feb 5, 1992 | SESE |
| K890303 | OPTI-TEARS(R) | Alcon Laboratories | Feb 17, 1989 | SESE |
| K880688 | SLC HARD LENS CLEANER | Ocular Pharmaceuticals, Inc. | Jun 28, 1988 | SESE |
| K881987 | DURACLEAN DAILY CLEANER | Allergan Optical | Jun 9, 1988 | SESE |
| K874364 | BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS | Bausch & Lomb, Inc. | Nov 25, 1987 | SESE |
| K872973 | W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION | Wesley Jessen Corp. | Oct 15, 1987 | SESE |
| K873548 | OPTI-ZYME(R) | Alcon Laboratories | Sep 29, 1987 | SESE |
| K872164 | RESTORE | Anderson Research, Inc. | Sep 17, 1987 | SESE |
| K871714 | KESTREL CONTACT LENS CASE | Applied Laboratories, Inc. | May 26, 1987 | SESE |
| K863846 | CONTAC CASE | S. M. C. Medi-Tech Corp. | Apr 6, 1987 | SESE |
| K863346 | PROFESSIONAL DISINFECTION SYSTEM (PDS) | Ciba Vision Care | Feb 27, 1987 | SESE |
| K870278 | CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695 | Ryder Intl. Corp. | Feb 20, 1987 | SESE |
| K864502 | THE CONTACT LENS ASSIST BRUSH | Young and Moore Enterprises, Inc. | Jan 20, 1987 | SESE |
| K864157 | OPTI-BRUSH | Willmar Contact Lens Clinic | Nov 13, 1986 | SESE |
| K843511 | BAUSCH & LOMB CLEANING PAD | Bausch & Lomb, Inc. | Oct 16, 1986 | SESE |
| K852386 | SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT | Barnes-Hind, Inc. | Sep 4, 1985 | SESE |
| N18143 | PREFLEX AND FLEXCARE SOL. | Alcon Laboratories | Apr 26, 1982 | APWD |
| N17945 | ADAPETTES | Alcon Laboratories | Oct 11, 1977 | APWD |
Top Applicants
- Bausch & Lomb, Inc. — 15 clearances
- Ciba Vision Corporation — 14 clearances
- Alcon Laboratories — 14 clearances
- Allergan, Inc. — 12 clearances
- Bausch & Lomb, Incorporated — 5 clearances
