Medical Device Manufacturer · US , Rochester , NY

Bausch & Lomb, Incorporated

27 submissions · 27 cleared · Since 2002
27
Total
27
Cleared
0
Denied

Bausch & Lomb, Incorporated — FDA 510(k) Submissions

Bausch & Lomb, Incorporated has submitted 27 FDA 510(k) premarket notifications since 2002, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lenses, Soft Contact, Daily Wear, Accessories, Soft Lens Products, Lens, Contact (other Material) - Daily, Products, Contact Lens Care, Rigid Gas Permeable, Case, Contact Lens . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
EyeGility? Inserter for Preloaded enVista IOLs
K242389 · MSS Folders And Injectors,... · Ophthalmic
Oct 2024 59d
Samfilcon B Custom Contact Lens
K230954 · LPL Lenses, Soft Contact,... · Ophthalmic
Nov 2023 227d
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
K220613 · LPL Lenses, Soft Contact,... · Ophthalmic
Mar 2023 370d
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · LPN Accessories, Soft Lens... · Ophthalmic
Dec 2022 106d
Independent Corneal Viewing Chamber (IVC-21)
K211786 · LYX Media, Corneal Storage · Ophthalmic
Dec 2021 177d
ABT12 multi-purpose solution
K202932 · LPN Accessories, Soft Lens... · Ophthalmic
May 2021 241d
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · LPL Lenses, Soft Contact,... · Ophthalmic
May 2021 53d
Boston One Step Liquid Enzymatic Cleaner
K200416 · MRC Products, Contact Lens... · Ophthalmic
Sep 2020 216d
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
K200528 · LPL Lenses, Soft Contact,... · Ophthalmic
Jun 2020 92d
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 Lens
K183167 · HQD Lens, Contact (other... · Ophthalmic
Feb 2019 89d
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K182249 · LPL Lenses, Soft Contact,... · Ophthalmic
Nov 2018 102d
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
K181627 · MRC Products, Contact Lens... · Ophthalmic
Aug 2018 51d
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
K173089 · MRC Products, Contact Lens... · Ophthalmic
Nov 2017 59d
Bausch + Lomb Boston Scleral Lens Case
K173365 · LRX Case, Contact Lens · Ophthalmic
Nov 2017 22d
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
K171404 · HQD Lens, Contact (other... · Ophthalmic
Jul 2017 66d
Bausch + Lomb Sensitive Eyes Plus Saline Solution
K170483 · LPN Accessories, Soft Lens... · Ophthalmic
Apr 2017 54d
NNR06 Multi-Purpose Solution
K161819 · LPN Accessories, Soft Lens... · Ophthalmic
Nov 2016 147d
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
K151918 · LPL Lenses, Soft Contact,... · Ophthalmic
Feb 2016 213d
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
K143632 · LPL Lenses, Soft Contact,... · Ophthalmic
Feb 2015 53d
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS
K132715 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2013 112d
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
K132216 · LPN Accessories, Soft Lens... · Ophthalmic
Sep 2013 54d
BAUSCH + LOMB NESOFILCON A CONTACT LENS
K113703 · LPL Lenses, Soft Contact,... · Ophthalmic
Jun 2012 172d
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K053124 · HQD Lens, Contact (other... · Ophthalmic
Jan 2006 84d
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · MRC Products, Contact Lens... · Ophthalmic
May 2003 130d
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · HQD Lens, Contact (other... · Ophthalmic
Aug 2002 52d
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