Lumenis Ltd
YOKNEAM Northern, IL
LUMENIS, LTD. appears in FDA device records in YOKNEAM Northern, IL. FDA records list 83 510(k) clearances between and , 6 PMA records and 3 registered establishments. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Lumenis Ltd carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Lumenis Be Ltdregistration, 510(k)
510(k) clearance history
Showing 50 of 83FDA records hold 83 510(k) clearances for Lumenis Ltd between 1979 and 2026. The busiest year on record is 2002, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 3 |
| 1982 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 6 |
| 2003 | 6 |
| 2004 | 1 |
| 2005 | 6 |
| 2006 | 3 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 1 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 4 |
| 2017 | 4 |
| 2018 | 1 |
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253803 | MILAN System | GEI | Substantially Equivalent | |
| K250809 | Stellar M22 | GEX | Substantially Equivalent | |
| K242349 | FoLix | GEX | Substantially Equivalent | |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | GEX | Substantially Equivalent | |
| K222790 | F65 Laser System | OAP | Substantially Equivalent | |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | HQF | Substantially Equivalent | |
| K211979 | Lumenis Y&R Laser System | GEX | Substantially Equivalent | |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | GEX | Substantially Equivalent | |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | GEX | Substantially Equivalent | |
| DEN200028 | Lumenis Stellar M22 | QIU | Unknown | |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | GEX | Substantially Equivalent | |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | Substantially Equivalent | |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | Substantially Equivalent | |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | GEX | Substantially Equivalent | |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | GEX | Substantially Equivalent | |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | GEX | Substantially Equivalent | |
| K170060 | M22 and ResurFx Systems | GEX | Substantially Equivalent | |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | GEX | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K151109 | Lumenis Smart532 Laser System | GEX | Substantially Equivalent | |
| K151947 | LightSheer Desire Light Laser System | GEX | Substantially Equivalent | |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch | GEX | Substantially Equivalent | |
| K142860 | Lumenis M22 System | GEX | Substantially Equivalent | |
| K133272 | VERSACUT + TISSUE MORCELLATOR | GCJ | Substantially Equivalent | |
| K133319 | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 | GEX | Substantially Equivalent | |
| K140388 | LUMENIS PULSE 120H | GEX | Substantially Equivalent | |
| K130195 | SCANNING LASERLINK | HQF | Substantially Equivalent | |
| K130028 | RESURFX 1565NM LASER MODULE | ONG | Substantially Equivalent | |
| K130164 | FIBERLASE ENDURE CO2 FIBER | GEX | Substantially Equivalent | |
| K111213 | VISION ONE LASER SYSTEM | GEX | Substantially Equivalent | |
| K100415 | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM | GEX | Substantially Equivalent | |
| K100384 | FIBERLASE C02 LASER WAVEGUIDE | GEX | Substantially Equivalent | |
| K100228 | VERSAPULSE MODEL P20 LASER SYSTEM | GEX | Substantially Equivalent | |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | ODF | Substantially Equivalent | |
| K083733 | LUME 2 SYSTEM, MODEL GA0005000 | GEX | Substantially Equivalent | |
| K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM | GEX | Substantially Equivalent | |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | GEX | Substantially Equivalent | |
| K060448 | LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. | GEX | Substantially Equivalent | |
| K053628 | LIGHTSHEER DUET LASER SYSTEM | GEX | Substantially Equivalent | |
| K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO | GEX | Substantially Equivalent | |
| K052526 | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES | GEX | Substantially Equivalent | |
| K051214 | ALUMA SKIN RENEWAL SYSTEM | GEI | Substantially Equivalent | |
| K051944 | FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES | HQF | Substantially Equivalent | |
| K052129 | LUMENIS 1000 INTEGRATED SLIT LAMP | GEX | Substantially Equivalent | |
| K050639 | LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM | GCJ | Substantially Equivalent | |
| K043173 | Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES | GEX | Substantially Equivalent | |
| K040270 | OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM | GEX | Substantially Equivalent | |
| K032357 | NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES | GEX | Substantially Equivalent | |
| K030033 | LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES | GEX | Substantially Equivalent | |
| K030342 | LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020611964 | 1720381 | LUMENIS BE INC. | 1870 South Milestone Drive, Salt Lake City, UT 84104 US | 2026 | |
| 3004135191 | 3004135191 | LUMENIS, LTD. | 6 HAKIDMA STREET PO BOX 240, YOKNEAM Northern 2069204 IL | 2026 | |
| 3021349626 | 3021349626 | Lumenis Be Ltd | 9 Hakidma St, POB # 426, Yokneam, Ha Zafon 2069236 Haifa 2069236 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- QIUIntense Pulsed Light Device For Managing Dry Eye
- GCJLaparoscope, General & Plastic Surgery
- OAPLaser, Comb, Hair
- EWGLaser, Ent Microsurgical Carbon-Dioxide
- HQFLaser, Ophthalmic
- FTCLight, Ultraviolet, Dermatological
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic
- ODFMini Endoscope, Gastroenterology-Urology
- GEXPowered Laser Surgical Instrument
- ONGPowered Laser Surgical Instrument With MicrobeamFractional Output
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- MVFSystem, Laser, Photodynamic Therapy
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2344-2025 | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue. | The potential for unsterilized product within finished product labeled as sterile. | Class II | Open, Classified | |
| Z-1290-2025 | (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. | The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on. | Class II | Open, Classified | |
| Z-0194-2022 | 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 | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health. | Class I | Terminated | |
| Z-0301-2017 | FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology. | The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. | Class II | Terminated | |
| Z-1669-2016 | Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). | Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device. | Class II | Terminated | |
| Z-2770-2015 | 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 removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited. | There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue. | Class II | Terminated | |
| Z-1519-2015 | 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, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation. | Class II | Terminated | |
| Z-2733-2014 | 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" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern. | Class II | Terminated | |
| Z-2191-2013 | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. | Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. | Class II | Terminated | |
| Z-0795-2013 | 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, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited. | Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up. | Class I | Terminated | |
| Z-2652-2010 | Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO | Firm did not have proper 510(K) clearance. | Terminated | ||
| Z-0585-2008 | 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. | Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size. | Terminated | ||
| Z-0028-2007 | 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 | Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use. | Terminated | ||
| Z-0556-06 | Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551 | During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip. | Terminated | ||
| Z-0545-06 | 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 | The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures. | Terminated | ||
| Z-0529-06 | 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 | Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain