Lumenis, Inc.

Country / Region:United States (US)Website:lumenis.com

510(k) submissions

15

Latest clearance

2022-06-21

Product codes

1

GEX

Cited as predicate

39

Product areas

FDA product code distribution

510(k) submissions

15 total

Showing 1–15

K number	Device name	Product code	Class	Decision
K211979	Lumenis Y&R Laser System	GEX	Class 2	2022-06-21
K212703	AcuPulse CO2 Laser System, Delivery Devices and Accessories	GEX	Class 2	2021-10-19
K203544	UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories	GEX	Class 2	2020-12-24
K202428	AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories	GEX	Class 2	2020-10-22
K201663	AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories	GEX	Class 2	2020-07-16
K193500	Stellar M22 for Intense Pulsed Light (IPL) and Laser System	GEX	Class 2	2020-01-16
K180597	AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO	GEX	Class 2	2018-04-03
K170179	LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity	GEX	Class 2	2017-09-18
K170060	M22 and ResurFx Systems	GEX	Class 2	2017-08-09
K170121	Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories	GEX	Class 2	2017-05-22
K162837	Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System	GEX	Class 2	2017-02-28
K151109	Lumenis Smart532 Laser System	GEX	Class 2	2015-10-30
K151947	LightSheer Desire Light Laser System	GEX	Class 2	2015-08-12
K151331	The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch	GEX	Class 2	2015-06-30
K142860	Lumenis M22 System	GEX	Class 2	2015-01-21

Company profile

Canonical name: Lumenis, Inc.
Aliases: Lumenis, Ltd., Lumenis
Country / Region: United States(US)
Website: lumenis.com

Predicate manufacturers

Companies whose devices this company cited as predicates

3

3 manufacturers

Citing manufacturers

Companies that cited this company's devices as predicates

21

21 manufacturers