LUMENIS, LTD.
FDA Regulatory Profile
LUMENIS, LTD. appears in FDA public data with 7 recalls — including 1 Class I (most serious) —, 76 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2344-2025, Class II) was initiated on July 22, 2025. Its most recent 510(k) clearance was granted on June 21, 2022.
Summary
- Total Recalls
- 7 (1 Class I)
- 510(k) Clearances
- 76
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2344-2025 | Class II | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation | July 22, 2025 |
| Z-1290-2025 | Class II | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM | January 23, 2025 |
| Z-0194-2022 | Class I | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009 | October 14, 2021 |
| Z-1669-2016 | Class II | Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). | November 17, 2015 |
| Z-2770-2015 | Class II | Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellat | July 30, 2015 |
| Z-2733-2014 | Class II | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory inten | August 15, 2014 |
| Z-2191-2013 | Class II | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the | August 19, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211979 | Lumenis Y&R Laser System | June 21, 2022 |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | October 19, 2021 |
| DEN200028 | Lumenis Stellar M22 | February 23, 2021 |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | December 24, 2020 |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | October 22, 2020 |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | July 16, 2020 |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | January 16, 2020 |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | April 3, 2018 |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | September 18, 2017 |
| K170060 | M22 and ResurFx Systems | August 9, 2017 |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | May 22, 2017 |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser Sys | February 28, 2017 |
| K151109 | Lumenis Smart532 Laser System | October 30, 2015 |
| K151947 | LightSheer Desire Light Laser System | August 12, 2015 |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family o | June 30, 2015 |
| K142860 | Lumenis M22 System | January 21, 2015 |
| K133272 | VERSACUT + TISSUE MORCELLATOR | May 13, 2014 |
| K133319 | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 | March 20, 2014 |
| K140388 | LUMENIS PULSE 120H | March 14, 2014 |
| K130195 | SCANNING LASERLINK | November 1, 2013 |