FDA 510(k) Applications for Medical Device Product Code "LPN"
(Accessories, Soft Lens Products)

FDA 510(k) Number Applicant Device Name Decision Date
K093254 ABBOTT MEDICAL OPTICS INC AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION 09/15/2010
K032030 ADVANCED MEDICAL OPTICS, INC. BLINK CL LUBRICANT EYE DROPS 09/25/2003
K030092 ADVANCED MEDICAL OPTICS, INC. COMPLETE BRAND MULTI-PURPOSE SOLUTION 04/04/2003
K042562 ADVANCED MEDICAL OPTICS, INC. LENS PLUS REWETTING DROPS 07/29/2005
K032481 ADVANCED VISION RESEARCH, INC. THERATEARS CONTACT LENS COMFORT DROPS 11/04/2003
K981574 ALCON OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION 07/06/1998
K973332 ALCON LABORATORIES ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 12/02/1997
K974624 ALCON LABORATORIES ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 03/04/1998
K981561 ALCON LABORATORIES LIQUID ENZYME ID 90133 07/24/1998
K983780 ALCON LABORATORIES MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 12/18/1998
K984575 ALCON LABORATORIES MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 01/14/1999
K984573 ALCON LABORATORIES OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP 09/16/1999
K974625 ALCON LABORATORIES OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER 03/04/1998
K990480 ALCON LABORATORIES OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER 05/10/1999
K981151 ALCON LABORATORIES OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392 06/22/1998
K983973 ALCON LABORATORIES OPTI-ONE MULTI-PURPOSE SOLUTION 12/18/1998
K191795 Alcon Laboratories, Inc. AOCup Lens Case with AODisc 07/31/2019
K162597 Alcon Laboratories, Inc. Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc 10/19/2016
K142284 ALCON LABORATORIES, INC. CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE 01/26/2015
K102860 ALCON RESEARCH, LTD. ALCON MULTI-PIRPOSE DISINFECTING SOLUTION 05/10/2011
K050729 ALCON RESEARCH, LTD. ALCON MULTI-PURPOSE DISINFECTING SOLUTION 09/14/2005
K001214 ALCON UNIVERSAL, LTD. OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION 07/10/2000
K002589 ALCON UNIVERSAL, LTD. OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION 10/23/2000
K021143 ALCON UNIVERSAL, LTD. OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION 08/08/2002
K071236 ALCON, INC. ALCON MULTI-PURPOSE SOLUTION 12/12/2007
K031193 ALCON, INC. SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION 07/03/2003
K190674 Allergan, Inc REFRESH RELIEVA For CONTACTS 08/08/2019
K000164 ALLERGAN, INC. COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION 06/02/2000
K003109 ALLERGAN, INC. COMPLETE BRAND LUBRICATING AND REWETTING DROPS 11/21/2000
K983150 ALLERGAN, INC. COMPLETE BRAND LUBRICATING AND REWETTING DROPS 11/25/1998
K013479 ALLERGAN, INC. COMPLETE BRAND MULTI-PURPOSE SOLUTION 02/11/2002
K014202 ALLERGAN, INC. COMPLETE BRAND MULTI-PURPOSE SOLUTION 02/20/2002
K003252 ALLERGAN, INC. COMPLETE BRAND MULTI-PURPOSE SOLUTION 02/21/2001
K980775 ALLERGAN, INC. COMPLETE BRAND MULTI-PURPOSE SOLUTION 07/06/1998
K981168 ALLERGAN, INC. COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS 09/01/1998
K992028 ALLERGAN, INC. REFRESH CONTACTS LUBRICATING AND REWETTING DROPS 10/07/1999
K083812 ALLERGAN, INC. REFRESH OPTIVE LENS COMFORT REWETTING DROPS 07/09/2009
K984383 ALLERGAN, INC. ULTRACARE NEUTRALIZING TABLETS 12/18/1998
K003031 ALPHA VISTA, INC. LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML 01/05/2001
K062332 ALTAIRE PHARMACEUTICALS, INC. ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION 04/25/2007
K980147 AUTOMATIC LIQUID PACKAGING, INC. YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION 04/13/1998
K202932 Bausch & Lomb Incorporated ABT12 multi-purpose solution 05/28/2021
K132216 BAUSCH & LOMB INCORPORATED BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION 09/09/2013
K222541 Bausch & Lomb Incorporated Bausch + Lomb Preservative Free Lubricating and Rewetting Drops 12/06/2022
K170483 Bausch & Lomb Incorporated Bausch + Lomb Sensitive Eyes Plus Saline Solution 04/11/2017
K161819 Bausch & Lomb Incorporated NNR06 Multi-Purpose Solution 11/25/2016
K031646 BAUSCH & LOMB, INC. BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 11/14/2003
K000247 BAUSCH & LOMB, INC. BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER 04/20/2000
K983225 BAUSCH & LOMB, INC. BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER 03/29/1999
K982775 BAUSCH & LOMB, INC. BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION 11/03/1998
K973921 BAUSCH & LOMB, INC. BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION 01/12/1998
K111877 BAUSCH & LOMB, INC. EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION 01/24/2012
K112909 BAUSCH & LOMB, INC. OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION 04/30/2012
K980591 BAUSCH & LOMB, INC. RENU MULTIPLUS LUBRICATING & REWETTING DROPS 06/24/1998
K002823 BAUSCH & LOMB, INC. RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION 10/17/2000
K001539 BAUSCH & LOMB, INC. RENU MULTIPLUS MULTI-PURPOSE SOLUTION 07/31/2000
K974723 BAUSCH & LOMB, INC. RENU MULTIPLUS MULTI-PURPOSE SOLUTION 03/10/1998
K990422 BAUSCH & LOMB, INC. RENU MULTIPLUS MULTI-PURPOSE SOLUTION 04/27/1999
K011796 BAUSCH & LOMB, INC. RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION 11/01/2001
K093367 CACHET PHARMACEUTICALS PVT. LTD. STERILE SALINE SOLUTION 09/10/2010
K102165 CACHET PHARMACEUTICALS PVT. LTD. STERILE SALINE SOLUTION 01/19/2011
K221263 Chemtex USA Inc. Aqua Naina Plus Sterile Saline Solution 10/12/2022
K193441 Chemtex USA, Inc. Aqua Naina Sterile Saline Solution 05/26/2020
K013512 CIBA VISION CORPORATION AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION 12/20/2001
K030522 CIBA VISION CORPORATION AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION 09/12/2003
K031521 CIBA VISION CORPORATION AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION 06/27/2003
K003345 CIBA VISION CORPORATION AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION 03/26/2001
K042176 CIBA VISION CORPORATION AQUIFY LENS COMFORT DROPS 11/03/2004
K033608 CIBA VISION CORPORATION AQUIFY MULTI-PURPOSE SOLUTION 02/02/2004
K050250 CIBA VISION CORPORATION AQUIFY MULTIPURPOSE SOLUTION 08/10/2005
K021635 CIBA VISION CORPORATION KARATS MULTIPURPOSE SOLUTION 10/28/2002
K031753 CIBA VISION CORPORATION KARATS MULTIPURPOSE SOLUTION 10/28/2004
K031957 CIBA VISION CORPORATION MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION 08/14/2003
K982168 CIBA VISION CORPORATION SOLO-CARE BRAND MULTI-PURPOSE SOLUTION 11/17/1998
K991403 CIBA VISION CORPORATION SOLO-CARE BRAND MULTI-PURPOSE SOLUTION 07/16/1999
K012731 CIBA VISION CORPORATION SOLO-CARE PLUS MULTIPURPOSE SOLUTION 12/26/2001
K031522 CIBA VISION CORPORATION SOLO-CARE PLUS MULTIPURPOSE SOLUTION 06/27/2003
K030910 CLUED UP LIMITED CLUED UP MULTIPURPOSE SOLUTION- NO RUB 10/10/2003
K070767 LAPIS LAZULI INTERNATIONAL NV EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION 07/24/2007
K051104 LAPIS LAZULI, NV EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION 05/31/2006
K990044 LOBOB LABORATORIES, INC. LOBOB UNIVERSAL CONTACT LENS CLEANER 02/11/1999
K191872 Menicon Co., Ltd. Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution 03/02/2020
K151768 MENICON CO.,LTD. Menicon Saline Rinse Solution 08/28/2015
K110221 OPTICS LABORATORY, INC EYE-CEPT STERILE SALINE SOLUTION 11/01/2011
K041008 OPTICS LABORATORY, INC. EYE-CEPT REWETTING DROPS 07/01/2005
K161622 Optics Laboratory, Inc. LensGiene Sterile Saline Solution 08/11/2016
K071203 OPTIKEM INTERNATIONAL, INC. SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES 06/13/2007
K000998 OPTISONIC, INC. OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES 06/05/2000
K210051 OTE North America LLC OTE MPS 045 Multi-purpose Lens Care Solution 05/26/2021
K991620 PFIZER, INC. VISINE FOR CONTACTS 09/24/1999
K980133 POLYMER TECHNOLOGY CORP. BAUSCH & LOMB WETTING AND SOAKING SOLUTION 03/11/1998
K973217 POLYMER TECHNOLOGY CORP. BOSTON LIQUID ENZYMATIC CLEANER 11/24/1997
K002319 PURILENS, INC. PURILENS SALINE SOLUTION 08/30/2000
K991125 SAUFLON PHARMACEUTICALS, LTD. SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES 09/14/1999
K010559 SAUFLON PHARMACEUTICALS, LTD. SAUFLON MULTI LENS CARE SYSTEM 12/20/2001
K130734 SAUFLON PHARMACEUTICALS, LTD. SAUFLON MULTIPURPOSE SOLUTION 05/15/2013
K030278 SAUFLON PHARMACEUTICALS, LTD. SAUFLON MULTIPURPOSE SOLUTION - NO RUB 07/30/2003
K974485 SZABOCSIK AND ASSOC. SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION 02/24/1998
K060924 SZABOCSIK AND ASSOCIATES JSZ MULTIACTION GP CONTACT LENS SOLUTION 06/28/2006
K050517 SZABOCSIK AND ASSOCIATES JSZ-MULTIPURPOSE SOLUTION 04/13/2005
K200747 The LifeStyle Company, Inc. PuriLens Plus Preservative Free Saline 05/15/2020
K011561 WILSA, INC. SEREINE EXTRA STRENGTH DAILY CLEANER 11/20/2001


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