Is this your brand? Sign in to claim ownership.
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
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (577)
Page 10 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Automatic Eye Safety Filter | Automatic Eye Safety Filter | FDA UDI | Class II | Unknown |
| VersaPulse PowerSuite 100W | VersaPulse PowerSuite 100W | FDA UDI | Class II | Active |
| Slimline Endo 365 Fiber | Slimline Endo 365 Fiber | FDA UDI | Class II | Active |
| FiberLase™ Small Sterilization Tray | FiberLase™ Small Sterilization Tray | FDA UDI | Class II | Active |
| Q-Switch Nd:YAG Disposable Tips Spot Size 5 mm | Q-Switch Nd:YAG Disposable Tips Spot Size 5 mm | FDA UDI | Class II | Unknown |
| Acculite EndoOcular | Illum/Sm Plug, 20ga str, SMA 906, 200µm | FDA UDI | Class II | Unknown |
| VersaPulse P20 | VersaPulse P20 | FDA UDI | Class II | Active |
| SapphireCool Light Guide 6 mm | SapphireCool Light Guide 6 mm | FDA UDI | Class II | Unknown |
| Stellar SapphireCool LG 15x35 | Stellar SapphireCool LG 15x35 | FDA UDI | Class II | Unknown |
| Lumenis Pulse 120H | Lumenis Pulse 120H | FDA UDI | Class II | Active |
| Lumenis Pulse 50H | Lumenis Pulse 50H | FDA UDI | Class II | Active |
| Acculite EndoOto | 24ga 15° Angled, SMA 905, 200µm | FDA UDI | Class II | Unknown |
| MicroSwitch Joystick | MicroSwitch Joystick | FDA UDI | Class II | Active |
| SS FiberLase™ HP-R 60 mm straight, curved tip | SS FiberLase™ HP-R 60 mm straight, curved tip | FDA UDI | Class II | Active |
| Laryngeal Probe Straight Tip 90 Degree Left Mirror Smoke Evacuation Channel | 14734 | FDA UDI | Class II | Active |
| Acculite EndoOcular | Standard, 20ga str taper, SMA 906, 200um | FDA UDI | Class II | Unknown |
| MicroSlad™ 717/718 Lens Slide 300 mm | 19108 | FDA UDI | Class II | Active |
| Lumenis Pulse, Moses 2.0 (DOM) | Lumenis Pulse, Moses 2.0 (DOM) | FDA UDI | Class II | Active |
| UltraPulse® Encore™ | Office | FDA UDI | Class II | Unknown |
| Multi-Application Handpiece Set 120° Mirror Tip | Multi-Application Handpiece Set 120° Mirror Tip | FDA UDI | Class II | Unknown |
| OtoScan™ Ear Aeration System | NTSC camera | FDA UDI | Class II | Active |
| Lumenis Pulse 60H, 50Hz | Lumenis Pulse 60H, 50Hz | FDA UDI | Class II | Active |
| Acculite EndoOcular | Standard, 20ga str taper, SMA 905, 200µm | FDA UDI | Class II | Unknown |
| Laryngeal Probe Straight Tip Smoke Evacuation Channel | 14732 | FDA UDI | Class II | Active |
| FiberLase™ HP-M 240 mm malleable | FiberLase™ HP-M 240 mm malleable | FDA UDI | Class II | Active |
| Slimline SIS 365 Fiber | Slimline SIS 365 Fiber | FDA UDI | Class II | Active |
| LightSheer Duet ET Handpiece | LightSheer Duet ET Handpiece | FDA UDI | Class II | Unknown |
| Lumenis Pulse, Moses 2.0 (INT) | Lumenis Pulse, Moses 2.0 (INT) | FDA UDI | Class II | Active |
| SlimLine™ SIS EZ 200 LP | SlimLine™ SIS EZ 200 LP | FDA UDI | Class II | Active |
| ResurFX Precision Tip | ResurFX Precision Tip | FDA UDI | Class II | Unknown |
| SS FiberLase™ Handpiece-M Kit | SS FiberLase™ Handpiece-M Kit | FDA UDI | Class II | Active |
| DeepFX™ Microscanner | DeepFX™ Microscanner | FDA UDI | Class II | Unknown |
| STC CO2 Fiber | STC CO2 Fiber | FDA UDI | Class II | Active |
| Digital AcuBlade™ Upgrade kit for UltraPulse® SurgiTouch™ | Kit for up to 007-xxxx, 110V | FDA UDI | Class II | Active |
| Universal IPL 695 nm Expert Filter | Universal IPL 695 nm Expert Filter | FDA UDI | Class II | Unknown |
| Lumenis Pulse 60H | Lumenis Pulse 60H, 50Hz | FDA UDI | Class II | Active |
| Lumenis Pulse 30H | Lumenis Pulse 30H | FDA UDI | Class II | Active |
| Xplume 9617 Smoke Evacuation 22 mm I.D. x 6 ft Plastic Hose Set | Xplume 9617 Smoke Evacuation 22 mm I.D. x 6 ft Plastic Hose Set | FDA UDI | Class II | Active |
| FiberLase™ Endoscope Protection Sheath | FiberLase™ Endoscope Protection Sheath | FDA UDI | Class II | Active |
| TrueSpot™ 2mm Handpiece | TrueSpot™ 2mm Handpiece | FDA UDI | Class II | Unknown |
| MicroSlad™ 719 Lens Slide 350 mm | 19104 | FDA UDI | Class II | Active |
| MicroSlad™ 719 Lens Slide 250 mm | 19102 | FDA UDI | Class II | Active |
| Holep Kit with SIS fiber for Versacut | Holep Kit with SIS fiber for Versacut | FDA UDI | Class II | Active |
| AcuPulse™ Upgrade Kit 40AES-F to 40AES-R | AcuPulse™ Upgrade Kit 40AES-F to 40AES-R | FDA UDI | Class II | Unknown |
| MicroSlad™ 719 Lens Slide 275 mm | 19119 | FDA UDI | Class II | Active |
| FiberLase™ HP-R 240 mm bent, curved tip | FiberLase™ HP-R 240 mm bent, curved tip | FDA UDI | Class II | Active |
| SS FiberLase™ HP-R 140 mm bent, straight tip | SS FiberLase™ HP-R 140 mm bent, straight tip | FDA UDI | Class II | Active |
| AcuScan™ 120 Microscanner Upgrade Kit | AcuScan™ 120 Microscanner Upgrade Kit | FDA UDI | Class II | Unknown |
| UltraScan™ CPG | UltraScan™ CPG | FDA UDI | Class II | Unknown |
| FiberLase™ HP-R 140 mm bent, straight tip | FiberLase™ HP-R 140 mm bent, straight tip | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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