Data / Medical devices / Israel / Lumenis Be Ltd
Lumenis Be Ltd: FDA-registered device maker in Yokneam, Ha Zafon 2069236 Haifa, Israel, 11 510(k) clearances
Lumenis Be Ltd is registered with the FDA (registration 3021349626) in Yokneam, Ha Zafon 2069236 Haifa, Israel. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021349626
- Address
- 9 Hakidma St, POB # 426 Yokneam Industrial Park, Yokneam, Ha Zafon 2069236 Haifa, Israel, 2069236
- Owner or operator
- Lumenis Be Ltd. (10082799)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 10, 2021
- Registered through
- 2026
- Brand names listed
- AcuPulse CO2 Laser System, AcuPulse Incisional Handpiece 125 mm, AcuPulse Upgrade Kit 40 to 40AES-F, AcuPulse Upgrade Kit 40 to 40AES-R, AcuPulse Upgrade Kit 40AES-F to 40AES-R, AcuPulse W Laser System, AcuScan 120 Microscanner, Black Stellar XPL HP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intense Pulsed Light Device For Managing Dry Eye | QIU | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 16, 2025 | K250809 | Stellar M22 | GEX | Substantially Equivalent | Lumenis Be, Ltd. | accessdata.fda.gov |
| September 9, 2024 | K242349 | FoLix | GEX | Substantially Equivalent | Lumenis Be, Ltd. | accessdata.fda.gov |
| December 1, 2023 | K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | GEX | Substantially Equivalent | Lumenis Be, Ltd. | accessdata.fda.gov |
| June 14, 2023 | K222790 | F65 Laser System | OAP | Substantially Equivalent | Lumenis Be, Ltd. | accessdata.fda.gov |
| October 19, 2021 | K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| February 23, 2021 | DEN200028 | Lumenis Stellar M22 | QIU | Unknown | Lumenis, Ltd. | accessdata.fda.gov |
| October 22, 2020 | K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| January 16, 2020 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| September 18, 2017 | K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| August 9, 2017 | K170060 | M22 and ResurFx Systems | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| April 15, 2003 | K030147 | LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Intense Pulsed Light Device For Managing Dry Eye
- All makers of Laser, Comb, Hair
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated April 16, 2025. 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.