FDA 510(k) Applications Submitted by Bausch & Lomb, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050948 |
04/15/2005 |
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K131208 |
04/29/2013 |
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, |
BAUSCH & LOMB, INC. |
| K082944 |
10/02/2008 |
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM |
BAUSCH & LOMB, INC. |
| K080755 |
03/17/2008 |
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K071043 |
04/12/2007 |
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
BAUSCH & LOMB, INC. |
| K011718 |
06/04/2001 |
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT |
BAUSCH & LOMB, INC. |
| K073184 |
11/13/2007 |
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS |
BAUSCH & LOMB, INC. |
| K040204 |
01/29/2004 |
ZYOPTIX XP MICROKERATOME |
BAUSCH & LOMB, INC. |
| K972454 |
07/01/1997 |
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K983894 |
11/03/1998 |
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K021640 |
05/20/2002 |
HANSATOME EXCELLUS MICROKERATOME |
BAUSCH & LOMB, INC. |
| K041998 |
07/26/2004 |
PHACO CHOP NEEDLES |
BAUSCH & LOMB, INC. |
| K022760 |
08/20/2002 |
MILLENNIUM MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
| K033653 |
11/21/2003 |
VENTURI PHACO PACK |
BAUSCH & LOMB, INC. |
| K033941 |
12/19/2003 |
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK |
BAUSCH & LOMB, INC. |
| K011199 |
04/19/2001 |
PROVIEW EYE PRESSURE MONITOR |
BAUSCH & LOMB, INC. |
| K994125 |
12/07/1999 |
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES |
BAUSCH & LOMB, INC. |
| K083757 |
12/17/2008 |
BPZ02 MULTIPURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
| K111877 |
07/01/2011 |
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION |
BAUSCH & LOMB, INC. |
| K113852 |
12/29/2011 |
BAUSCH & LOMB IOL INJECTOR |
BAUSCH & LOMB, INC. |
| K151102 |
04/24/2015 |
Bausch + Lomb Injector System |
Bausch & Lomb, Inc. |
| K980591 |
02/17/1998 |
RENU MULTIPLUS LUBRICATING & REWETTING DROPS |
BAUSCH & LOMB, INC. |
| K013232 |
09/27/2001 |
CYBERCASES BY BAUSCH & LOMB |
BAUSCH & LOMB, INC. |
| K050157 |
01/25/2005 |
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K063331 |
11/03/2006 |
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
| K071266 |
05/07/2007 |
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS |
BAUSCH & LOMB, INC. |
| K974780 |
12/22/1997 |
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K122575 |
08/23/2012 |
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI |
BAUSCH & LOMB, INC. |
| K063694 |
12/13/2006 |
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 |
BAUSCH & LOMB, INC. |
| K101325 |
05/12/2010 |
STELLARIS PC VISION ENHANCEMENT SYSTEM |
BAUSCH & LOMB, INC. |
| K062465 |
08/24/2006 |
ZYOPTIX XP EPI SEPARATOR SYSTEM |
BAUSCH & LOMB, INC. |
| K073023 |
10/26/2007 |
STERILS SINGLE-USE I/A HANDPIECES |
BAUSCH & LOMB, INC. |
| K082473 |
08/27/2008 |
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
| K990422 |
02/11/1999 |
RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
| K001539 |
05/17/2000 |
RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
| K031646 |
05/28/2003 |
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 |
BAUSCH & LOMB, INC. |
| K011796 |
06/08/2001 |
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
| K982775 |
08/07/1998 |
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
| K002823 |
09/11/2000 |
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION |
BAUSCH & LOMB, INC. |
| K973921 |
10/15/1997 |
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
| K974723 |
12/18/1997 |
RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
| K010260 |
01/29/2001 |
HANSATOME MICROKERATOME |
BAUSCH & LOMB, INC. |
| K012873 |
08/27/2001 |
DOCUMENTING LASER SLIT LAMP, DP 2010 |
BAUSCH & LOMB, INC. |
| K112192 |
07/29/2011 |
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K112909 |
10/03/2011 |
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION |
BAUSCH & LOMB, INC. |
| K012435 |
07/31/2001 |
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 |
BAUSCH & LOMB, INC. |
| K993039 |
09/10/1999 |
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) |
BAUSCH & LOMB, INC. |
| K000247 |
01/27/2000 |
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER |
BAUSCH & LOMB, INC. |
| K983225 |
09/14/1998 |
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER |
BAUSCH & LOMB, INC. |
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