Medical Device Manufacturer · US , Mchenry , IL

Bausch & Lomb, Inc.

92 submissions · 92 cleared · Since 1977
92
Total
92
Cleared
0
Denied

Bausch & Lomb, Inc. — FDA 510(k) Submissions

Bausch & Lomb, Inc. has submitted 92 FDA 510(k) premarket notifications since 1977, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Accessories, Soft Lens Products, Lenses, Soft Contact, Daily Wear, Unit, Phacofragmentation, Colorimeter, Photometer, Spectrophotometer For Clinical Use, Lens, Contact (polymethylmethacrylate) . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
Bausch + Lomb PreVue Inserter for enVista Preloaded
K192005 · MSS Folders And Injectors,... · Ophthalmic
Oct 2019 67d
Crystalsert Lens Delivery System
K173480 · MSS Folders And Injectors,... · Ophthalmic
Dec 2017 28d
Bausch + Lomb Injector System
K151102 · MSS Folders And Injectors,... · Ophthalmic
May 2015 28d
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K131208 · LPL Lenses, Soft Contact,... · Ophthalmic
Sep 2013 135d
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
K122575 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2012 119d
BAUSCH & LOMB IOL INJECTOR
K113852 · MSS Folders And Injectors,... · Ophthalmic
Sep 2012 274d
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
K112909 · LPN Accessories, Soft Lens... · Ophthalmic
Apr 2012 210d
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
K111877 · LPN Accessories, Soft Lens... · Ophthalmic
Jan 2012 207d
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · MVN Lens, Contact, (disposable) · Ophthalmic
Oct 2011 88d
STELLARIS PC VISION ENHANCEMENT SYSTEM
K101325 · HQC Unit, Phacofragmentation · Ophthalmic
Aug 2010 97d
BPZ02 MULTIPURPOSE SOLUTION
K083757 · LYL Accessories, Solution,... · Ophthalmic
Nov 2009 336d
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
K082473 · HQC Unit, Phacofragmentation · Ophthalmic
Jan 2009 131d
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · MSS Folders And Injectors,... · Ophthalmic
Oct 2008 14d
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
K082132 · HQC Unit, Phacofragmentation · Ophthalmic
Aug 2008 30d
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755 · MVN Lens, Contact, (disposable) · Ophthalmic
Jun 2008 85d
STERILS SINGLE-USE I/A HANDPIECES
K073023 · HQC Unit, Phacofragmentation · Ophthalmic
Mar 2008 138d
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
K073184 · HQD Lens, Contact (other... · Ophthalmic
Feb 2008 100d
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
K071266 · HQD Lens, Contact (other... · Ophthalmic
Aug 2007 100d
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K071043 · HQD Lens, Contact (other... · Ophthalmic
Aug 2007 112d
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
K063694 · KYB Lens, Guide, Intraocular · Ophthalmic
Mar 2007 84d
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
K063331 · HQC Unit, Phacofragmentation · Ophthalmic
Dec 2006 46d
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465 · HNO Keratome, Ac-powered · Ophthalmic
Sep 2006 13d
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K050948 · LPL Lenses, Soft Contact,... · Ophthalmic
May 2005 33d
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
K050157 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2005 91d
PHACO CHOP NEEDLES
K041998 · HQC Unit, Phacofragmentation · Ophthalmic
Aug 2004 21d

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