Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bausch & Lomb, Inc. — Predicate Candidate Screening

92 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

63 daysmedian FDA review time

146 days90th percentile

92clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192005	Bausch + Lomb PreVue Inserter for enVista Preloaded	Bausch & Lomb, Inc.	2019-10-04	67	0
K173480	Crystalsert Lens Delivery System	Bausch & Lomb, Inc.	2017-12-11	28	0
K151102	Bausch + Lomb Injector System	Bausch & Lomb, Inc.	2015-05-22	28	0
K131208	BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH	Bausch & Lomb, Inc.	2013-09-11	135	0
K122575	BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CO	Bausch & Lomb, Inc.	2012-12-20	119	0
K113852	BAUSCH & LOMB IOL INJECTOR	Bausch & Lomb, Inc.	2012-09-28	274	0
K112909	OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTIO	Bausch & Lomb, Inc.	2012-04-30	210	0
K111877	EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS0	Bausch & Lomb, Inc.	2012-01-24	207	0
K112192	NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTE	Bausch & Lomb, Inc.	2011-10-25	88	0
K101325	STELLARIS PC VISION ENHANCEMENT SYSTEM	Bausch & Lomb, Inc.	2010-08-17	97	1
K083757	BPZ02 MULTIPURPOSE SOLUTION	Bausch & Lomb, Inc.	2009-11-18	336	2
K082473	BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM	Bausch & Lomb, Inc.	2009-01-05	131	4
K082944	CRYSTALSERT CRYSTALENS DELIVERY SYSTEM	Bausch & Lomb, Inc.	2008-10-16	14	0
K082132	BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK	Bausch & Lomb, Inc.	2008-08-28	30	0
K080755	SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TIN	Bausch & Lomb, Inc.	2008-06-10	85	0
K073023	STERILS SINGLE-USE I/A HANDPIECES	Bausch & Lomb, Inc.	2008-03-12	138	0
K073184	BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION	Bausch & Lomb, Inc.	2008-02-21	100	0
K071266	BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS	Bausch & Lomb, Inc.	2007-08-15	100	0
K071043	BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON	Bausch & Lomb, Inc.	2007-08-02	112	0
K063694	AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28	Bausch & Lomb, Inc.	2007-03-07	84	0
K063331	BAUSCH & LOMB NGX MICROSURGICAL SYSTEM	Bausch & Lomb, Inc.	2006-12-19	46	12
K062465	ZYOPTIX XP EPI SEPARATOR SYSTEM	Bausch & Lomb, Inc.	2006-09-06	13	1
K050948	PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONT	Bausch & Lomb, Inc.	2005-05-18	33	0
K050157	MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS	Bausch & Lomb, Inc.	2005-04-26	91	0
K041998	PHACO CHOP NEEDLES	Bausch & Lomb, Inc.	2004-08-16	21	11
K040204	ZYOPTIX XP MICROKERATOME	Bausch & Lomb, Inc.	2004-03-22	53	4
K033941	MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK	Bausch & Lomb, Inc.	2004-02-10	53	1
K033653	VENTURI PHACO PACK	Bausch & Lomb, Inc.	2003-12-17	26	3
K031646	BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03	Bausch & Lomb, Inc.	2003-11-14	170	0
K022760	MILLENNIUM MICROSURGICAL SYSTEM	Bausch & Lomb, Inc.	2002-11-18	90	0
K021640	HANSATOME EXCELLUS MICROKERATOME	Bausch & Lomb, Inc.	2002-06-19	30	0
K013232	CYBERCASES BY BAUSCH & LOMB	Bausch & Lomb, Inc.	2001-11-20	54	0
K012873	DOCUMENTING LASER SLIT LAMP, DP 2010	Bausch & Lomb, Inc.	2001-11-19	84	0
K011796	RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION	Bausch & Lomb, Inc.	2001-11-01	146	0
K012435	ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626	Bausch & Lomb, Inc.	2001-10-02	63	0
K011718	BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISI	Bausch & Lomb, Inc.	2001-07-25	51	0
K011199	PROVIEW EYE PRESSURE MONITOR	Bausch & Lomb, Inc.	2001-07-02	74	0
K010260	HANSATOME MICROKERATOME	Bausch & Lomb, Inc.	2001-04-27	88	0
K002823	RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION	Bausch & Lomb, Inc.	2000-10-17	36	0
K001539	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	Bausch & Lomb, Inc.	2000-07-31	75	0
K000247	BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER	Bausch & Lomb, Inc.	2000-04-20	84	0
K994125	BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTAC	Bausch & Lomb, Inc.	2000-03-03	87	0
K993039	VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)	Bausch & Lomb, Inc.	2000-01-07	119	0
K990422	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	Bausch & Lomb, Inc.	1999-04-27	75	0
K983225	BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEAN	Bausch & Lomb, Inc.	1999-03-29	196	0
K983894	BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTA	Bausch & Lomb, Inc.	1998-11-18	15	0
K982775	BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION	Bausch & Lomb, Inc.	1998-11-03	88	0
K980591	RENU MULTIPLUS LUBRICATING & REWETTING DROPS	Bausch & Lomb, Inc.	1998-06-24	127	0
K974780	SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TIN	Bausch & Lomb, Inc.	1998-03-11	79	0
K974723	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	Bausch & Lomb, Inc.	1998-03-10	82	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda