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Sign in to claim this brandLumenis
US
Last updated May 23, 2026
What Lumenis makes
The company manufactures surgical laser systems, including solid-state and carbon dioxide laser platforms for general and ENT procedures, along with reusable and single-use beam guides and adaptors. Their portfolio also includes tissue morcellation systems and handpieces for powered tissue fragmentation, as well as micromanipulators for precise ENT surgery applications.
These devices are regulated under FDA classifications, with most falling under Class II and some under Class III. They are listed in the FDA’s 510(k), PMA, and UDI registries, reflecting their authorised status for commercial distribution in the US market.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Lumenis manufacture?
Lumenis specialises in surgical laser systems, including solid-state and carbon dioxide laser platforms designed for general and ENT (ear, nose, and throat) procedures. Their portfolio also includes reusable and single-use beam guides, laser adaptors, tissue morcellation systems, handpieces for tissue fragmentation, and micromanipulators for precise ENT surgery. These devices are engineered for applications like tissue ablation, coagulation, and fragmentation in various surgical settings.
Where is Lumenis based, and does that affect its regulatory oversight?
Lumenis is headquartered in the United States, which means its devices are subject to FDA regulatory oversight. The FDA classifies Lumenis’s products as either Class II or Class III, depending on their risk level and intended use. This classification determines the regulatory pathway for authorisation, such as 510(k) clearance for Class II devices or PMA approval for Class III devices, ensuring compliance with US market requirements.
Which regulatory registries list Lumenis’s devices?
Lumenis’s devices are listed in key FDA registries, including the 510(k) Premarket Notification Database, the Premarket Approval (PMA) Application Database, and the Unique Device Identifier (UDI) System. These registries track authorised devices for commercial distribution in the US, ensuring transparency and compliance with FDA requirements for surgical lasers and related systems.
How are Lumenis’s devices classified under FDA regulations?
Lumenis’s devices are classified under the FDA’s risk-based system, with most falling under Class II, which requires a 510(k) clearance to demonstrate substantial equivalence to a predicate device. Some higher-risk devices, such as certain laser systems or tissue morcellation tools, are classified as Class III, requiring a Premarket Approval (PMA) application to ensure safety and effectiveness before market authorisation. Classification depends on factors like procedural invasiveness and potential patient risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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Catalogue (577)
Page 8 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AcuScan™ 120 Microscanner Kit | AcuScan™ 120 Microscanner Kit | FDA UDI | Class II | Active |
| Stellar Optima System upgrade kit | Stellar Optima System upgrade kit | FDA UDI | Class II | Unknown |
| MicroSlad™ 719 Micromanipulator | MicroSlad™ 719 Micromanipulator | FDA UDI | Class II | Active |
| Universal IPL Filter Set | Universal IPL Filter Set | FDA UDI | Class II | Unknown |
| Slimline GI 365 Fiber | Slimline GI 365 Fiber | FDA UDI | Class II | Active |
| LaserLink HS | LaserLink HS | FDA UDI | Class II | Unknown |
| OptiLight IPL Upgrade Kit | OptiLight IPL Upgrade Kit | FDA UDI | Class II | Unknown |
| Multi-Application Handpiece Set 90° Mirror Tip | Multi-Application Handpiece Set 90° Mirror Tip | FDA UDI | Class II | Unknown |
| FiberLase™ Robotic Drop-In Guide | FiberLase™ Robotic Drop-In Guide | FDA UDI | Class II | Active |
| VersaCut™ Handpiece | VersaCut™ Handpiece | FDA UDI | Class II | Active |
| Xpeeda™ ENDO D/S/L | Xpeeda™ ENDO D/S/L | FDA UDI | Class II | Active |
| AcuSpot | AcuSpot 712 Micromanipulator | FDA UDI | Class II | Active |
| Versacut™ | Versacut™ | FDA UDI | Class II | Active |
| VersaCut Blade Set | VersaCut Blade Set | FDA UDI | Class II | Active |
| Duotome Sidelite 550 Fiber | Duotome Sidelite 550 Fiber | FDA UDI | Class II | Active |
| Lumenis Pulse 120H | Lumenis Pulse 120H | FDA UDI | Class II | Active |
| Fiber Inserts | 14621 | FDA UDI | Class II | Active |
| Lumenis Pulse 50H | Lumenis Pulse 50H | FDA UDI | Class II | Active |
| MicroSwitch Joystick | MicroSwitch Joystick | FDA UDI | Class II | Active |
| VersaCut Tissue Morcellator Control Unit | VersaCut Tissue Morcellator Control Unit | FDA UDI | Class II | Active |
| FiberLase™ HP-R 180 mm straight, straight tip | FiberLase™ HP-R 180 mm straight, straight tip | FDA UDI | Class II | Active |
| FiberLase™ HP-R 240 mm bent, straight tip | FiberLase™ HP-R 240 mm bent, straight tip | FDA UDI | Class II | Active |
| Lumenis Pulse 50H | Lumenis Pulse 50H | FDA UDI | Class II | Active |
| Nasal Probe Bent Tip | 14639 | FDA UDI | Class II | Active |
| LightSheer Infinity ET (9x9) Adaptor | LightSheer Infinity ET (9x9) Adaptor | FDA UDI | Class II | Unknown |
| Slimline SIS 550 Fiber | Slimline SIS 550 Fiber | FDA UDI | Class II | Active |
| LaserLink Z | LaserLink Z | FDA UDI | Class II | Unknown |
| LightSheer Desire Light | LightSheer Desire Light | FDA UDI | Class II | Unknown |
| Nasal Probe Straight Tip 90 Degree Left Mirror | 14633 | FDA UDI | Class II | Active |
| FiberLase™ Accessory Starter Kit with FiberLase Fiber | FiberLase™ Accessory Starter Kit with FiberLase Fiber | FDA UDI | Class II | Active |
| Stellar M22 Universal IPL Head | Stellar M22 Universal IPL Head | FDA UDI | Class II | Unknown |
| VersaCut+ Blade Set | VersaCut+ Blade Set | FDA UDI | Class II | Active |
| Automatic Eye Safety Filter | Automatic Eye Safety Filter | FDA UDI | Class II | Unknown |
| Digital AcuBlade™ for UltraPulse® SurgiTouch™ | Digital AcuBlade™ for UltraPulse® SurgiTouch™ | FDA UDI | Class II | Active |
| Lumenis Pulse 120H | Lumenis Pulse 120H | FDA UDI | Class II | Active |
| SL130 Slit Lamp & Table | SL130 Slit Lamp & Table | FDA UDI | Class II | Unknown |
| LightSheer® Desire | LightSheer Desire | FDA UDI | Class II | Unknown |
| LightSheer Infinity UHP 805 | LightSheer Infinity UHP 805 | FDA UDI | Class II | Unknown |
| ColpoSlad 726 Micromanipulator | ColpoSlad 726 Micromanipulator | FDA UDI | Class II | Active |
| Automatic Eye Safety Filter | Automatic Eye Safety Filter | FDA UDI | Class II | Unknown |
| Xplume 9611 Smoke Evacuation Secondary Filter | Xplume 9611 Smoke Evacuation Secondary Filter | FDA UDI | Class II | Active |
| Selecta Duet | Selecta Duet | FDA UDI | Class II | Unknown |
| Universal IPL 590 nm Expert Filter | Universal IPL 590 nm Expert Filter (Set 4) | FDA UDI | Class II | Unknown |
| Universal IPL Treatment Head | Universal IPL Treatment Head | FDA UDI | Class II | Unknown |
| BeamAlign Laparoscope Coupler 300mm | BeamAlign Laparoscope Coupler 300mm | FDA UDI | Class II | Active |
| Lumenis Pulse 120H | Lumenis Pulse 120H | FDA UDI | Class II | Active |
| Stellar M22 515 nm filter | Stellar M22 515 nm filter | FDA UDI | Class II | Unknown |
| FemTouch™ Adaptor kit | FemTouch™ Adaptor kit | FDA UDI | Class II | Unknown |
| OptiLight IPL Handpiece | OptiLight IPL Handpiece | FDA UDI | Class II | Unknown |
| Q-Switch Nd:YAG Disposable Tips Spot Size 2 mm | Q-Switch Nd:YAG Disposable Tips Spot Size 2 mm | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Lumenis has nine recall records listed in the FDA database, all initiated between April 8, 2005, and October 14, 2021, with all records marked as terminated. The reasons cited include potential unintended laser exposure, software errors leading to incorrect filter data, missing regulatory clearance, labeling discrepancies (e.g., incorrect fiber size markings), device design flaws (such as missing indicator markings or sapphire crystal debris), and contamination risks in associated ultrasound gels and lotions.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 14, 2021 | Z-0194-2022 | — | terminated | 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. |
| Aug 15, 2014 | Z-2733-2014 | — | terminated | 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. |
| Aug 19, 2013 | Z-2191-2013 | — | terminated | Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. |
| Jul 27, 2010 | Z-2652-2010 | — | terminated | Firm did not have proper 510(K) clearance. |
| Dec 18, 2007 | Z-0585-2008 | — | terminated | 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. |
| Aug 29, 2006 | Z-0028-2007 | — | terminated | 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. |
| Feb 9, 2006 | Z-0556-06 | — | terminated | During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip. |
| Feb 1, 2006 | Z-0545-06 | — | terminated | 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. |
| Apr 8, 2005 | Z-0529-06 | — | terminated | Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Lumenis, Ltd. YOKNEAM Northern · IL FEI 3004135191