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Bausch & Lomb, Incorporated

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252052 Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)HQC2026-03-25 View
510(k) K242389 EyeGility™ Inserter for Preloaded enVista IOLsMSS2024-10-10 View
510(k) K240169 Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC2024-07-26 View
510(k) K220613 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 PresbyopiaLPL2023-03-08 View
510(k) K222541 Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN2022-12-06 View
510(k) K202932 ABT12 multi-purpose solutionLPN2021-05-28 View
510(k) K210975 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaLPL2021-05-24 View
510(k) K200416 Boston One Step Liquid Enzymatic CleanerMRC2020-09-23 View
510(k) K183167 Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact LensHQD2019-02-12 View
510(k) K182249 Ultra (samfilcon A) Multifocal for Astigmatism Contact LensLPL2018-11-30 View
510(k) K181627 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic CleanerMRC2018-08-10 View
510(k) K180319 Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning SolutionMRC2018-03-27 View
510(k) K173089 Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning SolutionsMRC2017-11-27 View
510(k) K173365 Bausch + Lomb Boston Scleral Lens CaseLRX2017-11-17 View
510(k) K170483 Bausch + Lomb Sensitive Eyes Plus Saline SolutionLPN2017-04-11 View
510(k) K161819 NNR06 Multi-Purpose SolutionLPN2016-11-25 View
510(k) K151918 Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoistLPL2016-02-11 View
510(k) K132715 BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENSLPL2013-12-20 View
510(k) K132216 BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTIONLPN2013-09-09 View
510(k) K113703 BAUSCH + LOMB NESOFILCON A CONTACT LENSLPL2012-06-05 View
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