FDA 510(k) Applications Submitted by Bausch & Lomb Incorporated

FDA 510(k) Number Submission Date Device Name Applicant
K220613 03/03/2022 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia Bausch & Lomb Incorporated
K210975 04/01/2021 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia Bausch & Lomb Incorporated
K151918 07/13/2015 Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist BAUSCH & LOMB INCORPORATED
K182249 08/20/2018 Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens Bausch & Lomb Incorporated
K113703 12/16/2011 BAUSCH + LOMB NESOFILCON A CONTACT LENS BAUSCH & LOMB INCORPORATED
K022128 07/01/2002 BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB INCORPORATED
K013762 11/13/2001 RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB INCORPORATED
K161819 07/01/2016 NNR06 Multi-Purpose Solution Bausch & Lomb Incorporated
K132715 08/30/2013 BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS BAUSCH & LOMB INCORPORATED
K024289 12/23/2002 BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION BAUSCH & LOMB INCORPORATED
K143632 12/22/2014 Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens Bausch & Lomb Incorporated
K053124 11/07/2005 BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES BAUSCH & LOMB INCORPORATED
K170483 02/16/2017 Bausch + Lomb Sensitive Eyes Plus Saline Solution Bausch & Lomb Incorporated
K181627 06/20/2018 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner Bausch & Lomb Incorporated
K222541 08/22/2022 Bausch + Lomb Preservative Free Lubricating and Rewetting Drops Bausch & Lomb Incorporated
K173089 09/29/2017 Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions Bausch & Lomb Incorporated
K202932 09/29/2020 ABT12 multi-purpose solution Bausch & Lomb Incorporated
K173365 10/26/2017 Bausch + Lomb Boston Scleral Lens Case Bausch & Lomb Incorporated
K020802 03/12/2002 RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION BAUSCH & LOMB INCORPORATED
K200416 02/20/2020 Boston One Step Liquid Enzymatic Cleaner Bausch & Lomb Incorporated
K132216 07/17/2013 BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION BAUSCH & LOMB INCORPORATED


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