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

Lumenis, Ltd. — Predicate Candidate Screening

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

129 daysmedian FDA review time

243 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212703	AcuPulse CO2 Laser System, Delivery Devices and Accessories	Lumenis, Ltd.	2021-10-19	54	0
DEN200028	Lumenis Stellar M22	Lumenis, Ltd.	2021-02-23	309	0
K203544	UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery	Lumenis, Ltd.	2020-12-24	20	0
K202428	AcuPulse W CO2 Laser Systems, Delivery Devices and Accessori	Lumenis, Ltd.	2020-10-22	58	0
K201663	AcuPulse W CO2 Laser Systems, Delivery Devices and Accessori	Lumenis, Ltd.	2020-07-16	27	0
K193500	Stellar M22 for Intense Pulsed Light (IPL) and Laser System	Lumenis, Ltd.	2020-01-16	30	0
K180597	AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W	Lumenis, Ltd.	2018-04-03	28	0
K170179	LightSheer Desire; LightSheer Desire Light; LightSheer Duet;	Lumenis, Ltd.	2017-09-18	242	0
K170060	M22 and ResurFx Systems	Lumenis, Ltd.	2017-08-09	215	0
K170121	Lumenis Family of Holmium Surgical Lasers and Delivery Devic	Lumenis, Ltd.	2017-05-22	129	1
K162837	Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery de	Lumenis, Ltd.	2017-02-28	140	0
K151947	LightSheer Desire Light Laser System	Lumenis, Ltd.	2015-08-12	28	0
K151331	The UltraPulse system (UltraPulse and UltraPulse DUO models,	Lumenis, Ltd.	2015-06-30	42	0
K142860	Lumenis M22 System	Lumenis, Ltd.	2015-01-21	112	1
K133272	VERSACUT + TISSUE MORCELLATOR	Lumenis, Ltd.	2014-05-13	201	1
K133319	ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060	Lumenis, Ltd.	2014-03-20	143	0
K140388	LUMENIS PULSE 120H	Lumenis, Ltd.	2014-03-14	28	0
K130028	RESURFX 1565NM LASER MODULE	Lumenis, Ltd.	2013-09-03	243	0
K130164	FIBERLASE ENDURE CO2 FIBER	Lumenis, Ltd.	2013-03-24	60	1
K100384	FIBERLASE C02 LASER WAVEGUIDE	Lumenis, Ltd.	2010-04-12	55	0
K083733	LUME 2 SYSTEM, MODEL GA0005000	Lumenis, Ltd.	2009-05-04	139	0
K060448	LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.	Lumenis, Ltd.	2006-07-06	135	0
K043173	Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANT	Lumenis, Ltd.	2005-01-31	76	0
K040270	OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM	Lumenis, Ltd.	2004-12-16	315	0
K030033	LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES	Lumenis, Ltd.	2003-07-21	199	0
K030342	LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYS	Lumenis, Ltd.	2003-07-17	164	1
K024093	MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND CO	Lumenis, Ltd.	2003-06-19	190	0
K030147	LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS	Lumenis, Ltd.	2003-04-15	90	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