FDA 510(k) Applications for Medical Device Product Code "MRC"
(Products, Contact Lens Care, Rigid Gas Permeable)

FDA 510(k) Number Applicant Device Name Decision Date
K040839 ADVANCED MEDICAL OPTICS, INC. COMPLETE BLINK-N-CLEAN LENS DROPS 10/19/2004
K000148 ALCON LABORATORIES RGP MULTI-PURPOSE SOLUTION ID 100136 04/11/2000
K000385 ALCON UNIVERSAL, LTD. OPTI-FREE EXPRESS LENS DROPS 04/28/2000
K001235 ALCON UNIVERSAL, LTD. OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 07/03/2000
K173089 Bausch & Lomb Incorporated Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions 11/27/2017
K181627 Bausch & Lomb Incorporated Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner 08/10/2018
K024289 BAUSCH & LOMB INCORPORATED BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION 05/02/2003
K200416 Bausch & Lomb Incorporated Boston One Step Liquid Enzymatic Cleaner 09/23/2020
K180319 Bausch and Lomb Incorporated Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution 03/27/2018
K994170 BIOMATRIX, INC. HYLASHIELD CL 03/02/2000
K023455 CIBA VISION CORPORATION AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION 02/28/2003
K013204 CIBA VISION CORPORATION AQUIFY LENS COMFORT DROPS 04/03/2002
K000607 CIBA VISION CORPORATION SOLO-CARE BRAND HARD SOLUTION 05/15/2000
K993949 CIBA VISION CORPORATION SOLO-CARE BRAND HARD SOLUTION 01/05/2000
K983291 CIBA VISION CORPORATION SOLO-CARE BRAND MULTI-PURPOSE SOLUTION 11/25/1998
K181566 Contamac Ltd. Nutrifill 10/22/2018
K201069 Dry Eye Innovations, LLC VibrantVue Scleral Saline 07/31/2020
K014162 LOBOB LABORATORIES, INC. MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND 01/15/2002
K001964 LOBOB LABORATORIES, INC. OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION 07/18/2000
K001428 LOBOB LABORATORIES, INC. OPTIMUM WETTING AND REWETTING DROP 05/26/2000
K122273 MENICON CO. LTD. MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS 01/02/2013
K082855 MENICON CO. LTD. MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES 03/09/2010
K002140 MENICON CO. LTD. MENICON PROGENT REMOVER 10/10/2000
K020930 MENICON CO. LTD. MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES 05/02/2002
K130805 MENICON CO. LTD. MENICON UNIQUE PH MULTI-PURPOSE SOLUTION 07/03/2013
K173136 Menicon Co., Ltd. Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses 11/16/2017
K000975 NOF CORP. LIPIDURE REWETTING DROPS 09/25/2000
K182984 Omnivision AG MaxiTears Contacts PF 07/24/2019
K974466 POLYMER TECHNOLOGY CORP. BOSTON ADVANCE CLEANER 02/19/1998
K983836 POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. RIGID GAS PERMEABLE CONTACT LENS SOLUTION 02/11/1999
K011456 SAUFLON PHARMACEUTICALS, LTD. DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES 07/17/2001
K052074 SZABOCSIK AND ASSOCIATES JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, 09/01/2005


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