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

Lumenis, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time

186 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211979	Lumenis Y&R Laser System	Lumenis, Inc.	2022-06-21	361	0
K151109	Lumenis Smart532 Laser System	Lumenis, Inc.	2015-10-30	186	0
K130195	SCANNING LASERLINK	Lumenis, Inc.	2013-11-01	277	1
K111213	VISION ONE LASER SYSTEM	Lumenis, Inc.	2011-07-25	84	1
K100228	VERSAPULSE MODEL P20 LASER SYSTEM	Lumenis, Inc.	2010-02-24	29	0
K091962	POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OP	Lumenis, Inc.	2009-09-30	91	0
K082809	ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM	Lumenis, Inc.	2008-12-18	85	0
K081704	SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS	Lumenis, Inc.	2008-09-11	86	0
K053628	LIGHTSHEER DUET LASER SYSTEM	Lumenis, Inc.	2006-04-07	99	0
K060338	FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELE	Lumenis, Inc.	2006-03-09	27	0
K052526	NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES	Lumenis, Inc.	2005-11-15	62	0
K051214	ALUMA SKIN RENEWAL SYSTEM	Lumenis, Inc.	2005-10-24	165	0
K051944	FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SE	Lumenis, Inc.	2005-09-30	74	0
K052129	LUMENIS 1000 INTEGRATED SLIT LAMP	Lumenis, Inc.	2005-08-30	25	0
K050639	LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM	Lumenis, Inc.	2005-03-31	17	1
K032357	NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES	Lumenis, Inc.	2003-10-09	71	0
K022060	LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND	Lumenis, Inc.	2002-10-30	127	0
K022327	NOVUS SPECTRA	Lumenis, Inc.	2002-10-16	90	0
K020839	QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, V	Lumenis, Inc.	2002-10-11	210	0
K022181	NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCES	Lumenis, Inc.	2002-10-01	90	0
K021762	BCLEAR	Lumenis, Inc.	2002-08-23	86	0
K004006	SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC	Lumenis, Inc.	2001-03-26	90	0
K000498	COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER	Lumenis, Inc.	2000-03-13	27	0
K991258	NOVUS VERDI DELIVERY SYSTEMS	Lumenis, Inc.	1999-05-13	30	0
K990947	MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DU	Lumenis, Inc.	1999-04-27	36	0
K980685	MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS	Lumenis, Inc.	1998-05-20	86	0
K980079	COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES	Lumenis, Inc.	1998-04-09	90	0
K974789	COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND	Lumenis, Inc.	1998-03-09	77	0
K973470	COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPH	Lumenis, Inc.	1997-12-09	88	0
K972347	MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER	Lumenis, Inc.	1997-09-19	87	0
K960413	COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT	Lumenis, Inc.	1996-04-04	66	0
K951812	MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS	Lumenis, Inc.	1995-07-07	79	0
K946304	COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES	Lumenis, Inc.	1995-03-15	77	0
K933318	COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODE	Lumenis, Inc.	1994-07-08	354	0
K903689	COHERENT DIODE PHOTOCOAGULATOR	Lumenis, Inc.	1990-09-20	36	0
K902470	COHERENT XA30/SP AND XA50 SURGICAL LASERS	Lumenis, Inc.	1990-07-26	52	0
K895518	COHERENT HOLMIUM:YAG SURGICAL LASER	Lumenis, Inc.	1989-11-30	79	0
K895143	COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS	Lumenis, Inc.	1989-09-25	38	0
K820327	MODEL 450XL CO2 SURGICAL LASER	Lumenis, Inc.	1982-03-08	28	0
K812219	MODEL 900S INTRAOCULAR PROBE	Lumenis, Inc.	1981-11-16	102	0
K810740	ARGON MICROSURIGAL PROTOCOLS	Lumenis, Inc.	1981-08-21	155	0
K811153	COHERENT FLOUROTRON MASTER	Lumenis, Inc.	1981-06-16	50	0
K792083	HAAG-STREIT SLIT LAMP 900	Lumenis, Inc.	1979-11-16	31	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