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Lumenis, Inc.

FDA Regulatory Profile

Summary

Total Recalls
7 (1 Class I)
510(k) Clearances
76
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2344-2025Class IIOtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablationJuly 22, 2025
Z-1290-2025Class II(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOMJanuary 23, 2025
Z-0194-2022Class IIPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009October 14, 2021
Z-1669-2016Class IILumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).November 17, 2015
Z-2770-2015Class IILumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue MorcellatJuly 30, 2015
Z-2733-2014Class IIArray LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intenAugust 15, 2014
Z-2191-2013Class IIVision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in theAugust 19, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K211979Lumenis Y&R Laser SystemJune 21, 2022
K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesOctober 19, 2021
DEN200028Lumenis Stellar M22February 23, 2021
K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesDecember 24, 2020
K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesOctober 22, 2020
K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesJuly 16, 2020
K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemJanuary 16, 2020
K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOApril 3, 2018
K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinitySeptember 18, 2017
K170060M22 and ResurFx SystemsAugust 9, 2017
K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesMay 22, 2017
K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser SysFebruary 28, 2017
K151109Lumenis Smart532 Laser SystemOctober 30, 2015
K151947LightSheer Desire Light Laser SystemAugust 12, 2015
K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family oJune 30, 2015
K142860Lumenis M22 SystemJanuary 21, 2015
K133272VERSACUT + TISSUE MORCELLATORMay 13, 2014
K133319ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060March 20, 2014
K140388LUMENIS PULSE 120HMarch 14, 2014
K130195SCANNING LASERLINKNovember 1, 2013