Data / Medical devices / Israel / Lumenis, Ltd.
Lumenis, Ltd.: FDA-registered device maker in YOKNEAM Northern, Israel, 9 510(k) clearances
Lumenis, Ltd. is registered with the FDA (registration 3004135191) in YOKNEAM Northern, Israel. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 18, 2026. 7 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004135191
- Address
- 6 Hakidma Street Po Box 240 Yokneam Industrial Park, YOKNEAM Northern, Israel, 2069204
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 8, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2026 | K260100 | MOSES Raydar | GEX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 30, 2025 | K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | GEX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 24, 2020 | K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| April 3, 2018 | K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| May 22, 2017 | K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| June 30, 2015 | K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| March 24, 2013 | K130164 | FIBERLASE ENDURE CO2 FIBER | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| April 12, 2010 | K100384 | FIBERLASE C02 LASER WAVEGUIDE | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| March 31, 2005 | K050639 | LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM | GCJ | Substantially Equivalent | Lumenis, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 22, 2025 | 97279 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 23, 2025 | 96197 | Class II | Ongoing | (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. | accessdata.fda.gov |
| September 25, 2016 | 75384 | Class II | Terminated | 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. | accessdata.fda.gov |
| November 17, 2015 | 73765 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 30, 2015 | 71851 | Class II | Terminated | 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 | There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue. | accessdata.fda.gov |
| March 25, 2015 | 70863 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 2, 2013 | 63858 | Class I | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.