FDA 510(k) Applications Submitted by Barbara Klube-Falso

FDA 510(k) Number Submission Date Device Name Applicant
K200528 03/02/2020 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism Bausch + Lomb, Incorporated
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
K131208 04/29/2013 BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, BAUSCH & LOMB, INC.
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


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