Company ยท US
Lumenis, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2022. Name variants (Inc, Corp, punctuation) are merged.
76510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 71 |
| GCJ | Laparoscope, General & Plastic Surgery | 5 |
| HQF | Laser, Ophthalmic | 5 |
| FTC | Light, Ultraviolet, Dermatological | 3 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| ODF | Mini Endoscope, Gastroenterology-Urology | 1 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 1 |
| QIU | Intense Pulsed Light Device For Managing Dry Eye | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2022 | K211979 | Lumenis Y&R Laser System Lumenis, Inc. | GEX |
| Oct 19, 2021 | K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories Lumenis, Ltd., IL | GEX |
| Feb 23, 2021 | DEN200028 | Lumenis Stellar M22 Lumenis, Ltd., IL | QIU |
| Dec 24, 2020 | K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories Lumenis, Ltd., IL | GEX |
| Oct 22, 2020 | K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories Lumenis, Ltd., IL | GEX |
| Jul 16, 2020 | K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories Lumenis, Ltd., IL | GEX |
| Jan 16, 2020 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System Lumenis, Ltd., IL | GEX |
| Apr 3, 2018 | K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO Lumenis, Ltd., IL | GEX |
| Sep 18, 2017 | K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity Lumenis, Ltd., IL | GEX |
| Aug 9, 2017 | K170060 | M22 and ResurFx Systems Lumenis, Ltd., IL | GEX |
| May 22, 2017 | K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories Lumenis, Ltd., IL | GEX |
| Feb 28, 2017 | K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision Lumenis, Ltd., IL | GEX |
| Oct 30, 2015 | K151109 | Lumenis Smart532 Laser System Lumenis, Inc. | GEX |
| Aug 12, 2015 | K151947 | LightSheer Desire Light Laser System Lumenis, Ltd., IL | GEX |
| Jun 30, 2015 | K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTo Lumenis, Ltd., IL | GEX |
| Jan 21, 2015 | K142860 | Lumenis M22 System Lumenis, Ltd., IL | GEX |
| May 13, 2014 | K133272 | VERSACUT + TISSUE MORCELLATOR Lumenis, Ltd., IL | GCJ |
| Mar 20, 2014 | K133319 | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 Lumenis, Ltd., IL | GEX |
| Mar 14, 2014 | K140388 | LUMENIS PULSE 120H Lumenis, Ltd., IL | GEX |
| Nov 1, 2013 | K130195 | SCANNING LASERLINK Lumenis, Inc. | HQF |
| Sep 3, 2013 | K130028 | RESURFX 1565NM LASER MODULE Lumenis, Ltd., IL | ONG |
| Mar 24, 2013 | K130164 | FIBERLASE ENDURE CO2 FIBER Lumenis, Ltd., IL | GEX |
| Jul 25, 2011 | K111213 | VISION ONE LASER SYSTEM Lumenis, Inc. | GEX |
| Apr 21, 2010 | K100415 | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM Lumenis, IL | GEX |
| Apr 12, 2010 | K100384 | FIBERLASE C02 LASER WAVEGUIDE Lumenis, Ltd., IL | GEX |
| Feb 24, 2010 | K100228 | VERSAPULSE MODEL P20 LASER SYSTEM Lumenis, Inc. | GEX |
| Sep 30, 2009 | K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 Lumenis, Inc. | ODF |
| May 4, 2009 | K083733 | LUME 2 SYSTEM, MODEL GA0005000 Lumenis, Ltd. | GEX |
| Dec 18, 2008 | K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM Lumenis, Inc. | GEX |
| Sep 11, 2008 | K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS Lumenis, Inc. | GEX |
| Jul 6, 2006 | K060448 | LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. Lumenis, Ltd. | GEX |
| Apr 7, 2006 | K053628 | LIGHTSHEER DUET LASER SYSTEM Lumenis, Inc. | GEX |
| Mar 9, 2006 | K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO Lumenis, Inc. | GEX |
| Nov 15, 2005 | K052526 | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES Lumenis, Inc. | GEX |
| Oct 24, 2005 | K051214 | ALUMA SKIN RENEWAL SYSTEM Lumenis, Inc. | GEI |
| Sep 30, 2005 | K051944 | FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES Lumenis, Inc. | HQF |
| Aug 30, 2005 | K052129 | LUMENIS 1000 INTEGRATED SLIT LAMP Lumenis, Inc. | GEX |
| Mar 31, 2005 | K050639 | LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM Lumenis, Inc. | GCJ |
| Jan 31, 2005 | K043173 | Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES Lumenis, Ltd. | GEX |
| Dec 16, 2004 | K040270 | OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM Lumenis, Ltd. | GEX |
| Oct 9, 2003 | K032357 | NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES Lumenis, Inc. | GEX |
| Jul 21, 2003 | K030033 | LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES Lumenis, Ltd. | GEX |
| Jul 17, 2003 | K030342 | LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS Lumenis, Ltd. | GEX |
| Jun 19, 2003 | K024093 | MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS Lumenis, Ltd. | GEX |
| May 20, 2003 | K030527 | LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS Lumenis | GEX |
| Apr 15, 2003 | K030147 | LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS Lumenis, Ltd. | GEX |
| Oct 30, 2002 | K022060 | LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES Lumenis, Inc. | GEX |
| Oct 16, 2002 | K022327 | NOVUS SPECTRA Lumenis, Inc. | GEX |
| Oct 11, 2002 | K020839 | QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL Lumenis, Inc. | GEX |
| Oct 1, 2002 | K022181 | NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES Lumenis, Inc. | GEX |
Newest 50 of 76.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2025 | LUMENIS, LTD. OtoLase Starter Kit;
UPN: AC-2003748.
Indicated for a
variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue. Open, Classified |
GEX | K130164 |
| Mar 5, 2025 | LUMENIS, LTD. (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System;
(2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and
(3) Lumenis Pulse 120H, REF GA-0008700, Laser System. Open, Classified |
GEX | K170121 |
| Nov 4, 2021 | Lumenis, Inc. IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical Terminated |
ITX | K955246 |
| Oct 23, 2016 | Lumenis Limited FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590)
Provide fractional treatments in gynecology. Terminated |
GEX | K100415 |
| May 13, 2016 | Lumenis Ltd Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). Terminated |
GEX | K142860 |
| Sep 16, 2015 | Lumenis Lumenis VersaCut+ Tissue Morcellator GA-0007500
The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and remova Terminated |
GCJ | K133272 |
| Apr 24, 2015 | Lumenis Limited Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Terminated |
GEX | K003614 |
| Sep 30, 2014 | Lumenis, Inc. Array LaserLink, Manufactured by Lumenis,
The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" Terminated |
HQF | K130195 |
| Sep 11, 2013 | Lumenis, Inc. Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053.
Intended for use in the treatment of ocular pathology. Terminated |
GEX | K111213 |
| Feb 14, 2013 | Lumenis Limited The Lumenis VersaCut Tissue Morcellator
Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparosc Terminated |
GCJ | K050639 |
| Sep 30, 2010 | Lumenis, Inc. Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO Terminated |
HQF | None listed |
| Apr 9, 2008 | Lumenis, Inc. Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL. Terminated |
GEX | K011703 |
| Oct 12, 2006 | Lumenis Inc. Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue.
Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA Terminated |
GEX | K011703 |
| Mar 2, 2006 | Lumenis Inc. Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems;
Manufactured before November 4, 2003;
Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104 Terminated |
GEX | K913569 K990179 |
| Feb 23, 2006 | Lumenis Inc. Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers;
Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551 Terminated |
GEX | K003614 |
| Feb 16, 2006 | Lumenis Inc. Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692 Terminated |
GEX | K030342 |