Lumenis, Inc.
Medical device manufacturer in Ilit, Isra.
75510(k) clearances
2PMA approvals
13recalls
Device types
- GEX Powered Laser Surgical Instrument 60
- HQF Laser, Ophthalmic 3
- GCJ Laparoscope, General & Plastic Surgery 3
- FTC Light, Ultraviolet, Dermatological 3
- HRM Microscope, Operating & Accessories… 1
- HJO Biomicroscope, Slit-Lamp, Ac-Powered 1
- EWG Laser, Ent Microsurgical Carbon-Dioxide 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- ODF Mini Endoscope, Gastroenterology-Urology 1
- ONG Powered Laser Surgical Instrument With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K211979 | Lumenis Y&R Laser SystemGEX · Traditional | 06/21/2022SE |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and AccessoriesGEX · Traditional | 10/19/2021SE |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesGEX · Special | 12/24/2020SE |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEX · Special | 10/22/2020SE |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEX · Special | 07/16/2020SE |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemGEX · Special | 01/16/2020SE |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOGEX · Special | 04/03/2018SE |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX · Traditional | 09/18/2017SE |
| K170060 | M22 and ResurFx SystemsGEX · Special | 08/09/2017SE |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesGEX · Special | 05/22/2017SE |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus…GEX · Traditional | 02/28/2017SE |
| K151109 | Lumenis Smart532 Laser SystemGEX · Traditional | 10/30/2015SE |
| K151947 | LightSheer Desire Light Laser SystemGEX · Special | 08/12/2015SE |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified…GEX · Special | 06/30/2015SE |
| K142860 | Lumenis M22 SystemGEX · Traditional | 01/21/2015SE |
| K133272 | Versacut + Tissue MorcellatorGCJ · Traditional | 05/13/2014SE |
| K133319 | Et Lightsheer 1060, High Speed Lightsheer 1060GEX · Traditional | 03/20/2014SE |
| K140388 | Lumenis Pulse 120HGEX · Special | 03/14/2014SE |
| K130195 | Scanning LaserlinkHQF · Abbreviated | 11/01/2013SE |
| K130028 | Resurfx 1565NM Laser ModuleONG · Traditional | 09/03/2013SE |
| K130164 | Fiberlase Endure CO2 FiberGEX · Special | 03/24/2013SE |
| K111213 | Vision One Laser SystemGEX · Special | 07/25/2011SE |
| K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemGEX · Traditional | 04/21/2010SE |
| K100384 | Fiberlase C02 Laser WaveguideGEX · Special | 04/12/2010SE |
| K100228 | Versapulse Model P20 Laser SystemGEX · Special | 02/24/2010SE |
| K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…ODF · Traditional | 09/30/2009SE |
| K083733 | Lume 2 System, Model GA0005000GEX · Traditional | 05/04/2009SE |
| K082809 | Acupulse 30 and 40 Carbon Dioxide Laser SystemGEX · Traditional | 12/18/2008SE |
| K081704 | Selecta Family of Ophithalmic Laser SystemsGEX · Traditional | 09/11/2008SE |
| K060448 | Lumenis One Family of Systems; Lumenis One.GEX · Traditional | 07/06/2006SE |
| K053628 | Lightsheer Duet Laser SystemGEX · Traditional | 04/07/2006SE |
| K060338 | Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta Duet…GEX · Special | 03/09/2006SE |
| K052526 | Novus 3000 Laser System and Delivery DevicesGEX · Traditional | 11/15/2005SE |
| K051214 | Aluma Skin Renewal SystemGEI · Traditional | 10/24/2005SE |
| K051944 | Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo)…HQF · Traditional | 09/30/2005SE |
| K052129 | Lumenis 1000 Integrated Slit LampGEX · Traditional | 08/30/2005SE |
| K050639 | Lumenis Versacut Tissue Morcellator SystemGCJ · Special | 03/31/2005SE |
| K043173 | Q-Switched Nd:Yag Laser Treatment Head for the Lumenis Quantum SeriesGEX · Traditional | 01/31/2005SE |
| K040270 | Opusduo; Opusduo E; Opusduo Ec; Opus 20; Opus SpectrumGEX · Traditional | 12/16/2004SE |
| K032357 | Novus TTX Laser and Delivery Devices with AccessoriesGEX · Traditional | 10/09/2003SE |
| K030033 | Lumenis Family of Disposable Contact Tip Delivery DevicesGEX · Traditional | 07/21/2003SE |
| K030342 | Lumenis Family of Ipl Systems and Combination Ipl/Nd:Yag SystemsGEX · Traditional | 07/17/2003SE |
| K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…GEX · Traditional | 06/19/2003SE |
| K030527 | Lumenis Family of Ipl and Combination Ipl/Nd:Yag SystemsGEX · Traditional | 05/20/2003SE |
| K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersGEX · Traditional | 04/15/2003SE |
| K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesGEX · Traditional | 10/30/2002SE |
| K022327 | Novus SpectraGEX · Traditional | 10/16/2002SE |
| K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLGEX · Traditional | 10/11/2002SE |
| K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesGEX · Traditional | 10/01/2002SE |
| K021762 | BclearFTC · Traditional | 08/23/2002SE |
| K020591 | BclearFTC · Traditional | 05/16/2002SE |
| K011197 | Dermaclear Uv-B Phototherapy SystemFTC · Traditional | 12/14/2001SE |
| K011703 | Lumenis Versapulse Powersuite Holmium (Ho:Yag) and Dual Wavelength (Ho:Yag/Nd:Yag)…GEX · Traditional | 08/29/2001SE |
| K004006 | Selecta 7000 Frequency Doubled, Q-Switched Nd:Yag Ophthalmic LaserGEX · Traditional | 03/26/2001SE |
| K000498 | Coherent Laserlink Z-1000 Slit Lamp Laser Delivery AdapterGEX · Special | 03/13/2000SE |
| K991258 | Novus Verdi Delivery SystemsGEX · Traditional | 05/13/1999SE |
| K990947 | Modified Versapulse Select Single Wavelength, Ho: Yag and Dual Wavelength, Ho: Yag/Nd:…GEX · Traditional | 04/27/1999SE |
| K980685 | Modified Versapulse Select Ho:Yag and Ho:Yag/Nd:Yag LasersGEX · Traditional | 05/20/1998SE |
| K980079 | Coherent Tissue Morcellator Kit and AccessoriesGCJ · Traditional | 04/09/1998SE |
| K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LGEX · Traditional | 03/09/1998SE |
| K973470 | Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in…GEX · Traditional | 12/09/1997SE |
| K972347 | Modified Coherent Versapulse Aesthetic Surgical LaserGEX · Traditional | 09/19/1997SE |
| K960413 | Coherent Slimline Single Lumen Aspiration Needle KitGEX · Traditional | 04/04/1996SE |
| K951812 | Modified Coherent Ultrapulse CO2 Surgical LasersGEX · Traditional | 07/07/1995SE |
| K946304 | Coherent Family of CO2 Surgical Laser Scanner HandpiecesGEX · Traditional | 03/15/1995SE |
| K933318 | Coherent Versapulse 2.1U /1.06U Compact Surgical Laser, Models a & BGEX · Traditional | 07/08/1994SE |
| K903689 | Coherent Diode PhotocoagulatorGEX · Traditional | 09/20/1990SE |
| K902470 | Coherent XA30/SP and XA50 Surgical LasersGEX · Traditional | 07/26/1990SE |
| K895518 | Coherent Holmium:Yag Surgical LaserGEX · Traditional | 11/30/1989SE |
| K895143 | Coherent XA-50, X30/CW, XA30/SP Surgical LasersGEX · Traditional | 09/25/1989SE |
| K820327 | Model 450XL CO2 Surgical LaserGEX · Traditional | 03/08/1982SE |
| K812219 | Model 900S Intraocular ProbeHQF · Traditional | 11/16/1981SE |
| K810740 | Argon Microsurigal ProtocolsEWG · Traditional | 08/21/1981SE |
| K811153 | Coherent Flourotron MasterHJO · Traditional | 06/16/1981SE |
| K792083 | Haag-Streit Slit Lamp 900HRM · Traditional | 11/16/1979SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2344-2025 Class II | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including…The potential for unsterilized product within finished product labeled as sterile. | 07/22/2025Open, Classified |
| Z-1290-2025 Class II | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H…The initial current in certain chargers may lead to overheating and damage to the power resistors on the… | 01/23/2025Open, Classified |
| Z-0194-2022 Class I | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L…Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial… | 10/14/2021Terminated |
| Z-0301-2017 Class II | FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip…The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled… | 09/25/2016Terminated |
| Z-1669-2016 Class II | Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter…Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to… | 11/17/2015Terminated |
| Z-2770-2015 Class II | Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue…There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation… | 07/30/2015Terminated |
| Z-1519-2015 Class II | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual… | 03/25/2015Terminated |
| Z-2733-2014 Class II | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system…Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system… | 08/15/2014Terminated |
| Z-2191-2013 Class II | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for…Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended… | 08/19/2013Terminated |
| Z-0795-2013 Class I | The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct…Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a… | 01/02/2013Terminated |
| Z-2652-2010 | Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EOFirm did not have proper 510(K) clearance. | 07/27/2010Terminated |
| Z-0585-2008 | Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No.…Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed… | 12/18/2007Terminated |
| Z-0028-2007 | Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating…Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation… | 08/29/2006Terminated |