FDA 510(k) Applications Submitted by Lumenis Ltd.

FDA 510(k) Number	Submission Date	Device Name	Applicant
K180597	03/06/2018	AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO	Lumenis Ltd.
K170179	01/19/2017	LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity	Lumenis Ltd.
K040270	02/05/2004	OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM	LUMENIS LTD.
K133319	10/28/2013	ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060	LUMENIS LTD.
K060448	02/21/2006	LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.	LUMENIS LTD.
K140388	02/14/2014	LUMENIS PULSE 120H	LUMENIS LTD.
DEN200028	04/20/2020	Lumenis Stellar M22	Lumenis Ltd.
K201663	06/19/2020	AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories	Lumenis Ltd.
K202428	08/25/2020	AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories	Lumenis Ltd.
K203544	12/04/2020	UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories	Lumenis Ltd.
K193500	12/17/2019	Stellar M22 for Intense Pulsed Light (IPL) and Laser System	Lumenis Ltd.
K170121	01/13/2017	Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories	Lumenis Ltd.
K130164	01/23/2013	FIBERLASE ENDURE CO2 FIBER	LUMENIS LTD.
K142860	10/01/2014	Lumenis M22 System	Lumenis Ltd.
K133272	10/24/2013	VERSACUT + TISSUE MORCELLATOR	LUMENIS LTD.