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Lumenis

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
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Catalogue (577)

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Device	Model / Reference	Registries	Class	Status
Lumenis Versapulse Powersuite Holmium (ho:yag) And Dual Wavelength (ho:yag/Nd:yag) Surgical Lasers And Delivery Devices	K011703	FDA 510(k)	Class II	Active
Lumenis Stellar M22	DEN200028	FDA 510(k)	Class II	Active
Scanning Laserlink	K130195	FDA 510(k)	Class II	Active
Coherent Slimline Single Lumen Aspiration Needle Kit	K960413	FDA 510(k)	Class II	Active
Coherent Xa30/Sp And Xa50 Surgical Lasers	K902470	FDA 510(k)	Class II	Active
Aluma Skin Renewal System	K051214	FDA 510(k)	Class II	Active
Novus 3000 Laser System And Delivery Devices	K052526	FDA 510(k)	Class II	Active
Modified Lumenis Family Of Intense Pulsed-Light (ipl) And Combination Ipl Systems And Nd:yag Laser Systems	K024093	FDA 510(k)	Class II	Active
Lumenis Family Of Disposable Contact Tip Delivery Devices	K030033	FDA 510(k)	Class II	Active
Et Lightsheer 1060, High Speed Lightsheer 1060	K133319	FDA 510(k)	Class II	Active
Lumenis M22 System	K142860	FDA 510(k)	Class II	Active
Selecta Family Of Ophithalmic Laser Systems	K081704	FDA 510(k)	Class II	Active
Model 450xl Co2 Surgical Laser	K820327	FDA 510(k)	Class II	Active
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories	K203544	FDA 510(k)	Class II	Active
Dermaclear Uv-B Phototherapy System	K011197	FDA 510(k)	Class II	Active
Coherent Diode Photocoagulator	K903689	FDA 510(k)	Class II	Active
Acupulse 30/40 St Co2 Laser System And Acupulse 40wg Co2 Laser System	K100415	FDA 510(k)	Class II	Active
Family Of Selecta Laser Systems Including Selecta 1064, Selecta Slt, Selecta Duet, Selecta Duo, Selecta Trio	K060338	FDA 510(k)	Class II	Active
Lumenis Family Of Ipl Systems And Combination Ipl/Nd:yag Systems	K030342	FDA 510(k)	Class II	Active
Lumenis Versacut Tissue Morcellator System	K050639	FDA 510(k)	Class II	Active
Coherent Flourotron Master	K811153	FDA 510(k)	Class II	Active
Stellar M22 for Intense Pulsed Light (IPL) and Laser System	K193500	FDA 510(k)	Class II	Active
Q-Switched Nd:yag Laser Treatment Head For The Lumenis Quantum Series	K043173	FDA 510(k)	Class II	Active
Bclear	K021762	FDA 510(k)	Class II	Active
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories	K201663	FDA 510(k)	Class II	Active
Modified Coherent Ultrapulse Co2 Surgical Lasers	K951812	FDA 510(k)	Class II	Active
LightSheer Desire Light Laser System	K151947	FDA 510(k)	Class II	Active
Modified Coherent Versapulse Aesthetic Surgical Laser	K972347	FDA 510(k)	Class II	Active
Versacut + Tissue Morcellator	K133272	FDA 510(k)	Class II	Active
Quantum, Models Sr, Hr, Dl; Vasculight, Models Sr, Hr, Vs, Vx, Dl	K020839	FDA 510(k)	Class II	Active
Fiberlase C02 Laser Waveguide	K100384	FDA 510(k)	Class II	Active
Acupulse 30 And 40 Carbon Dioxide Laser System	K082809	FDA 510(k)	Class II	Active
Polyscope Flexible Endoscopy Catheter; 10, 000 Pixel Fiber Optic; Xenon Light Source, Model Ls-200	K091962	FDA 510(k)	Class II	Active
Coherent Ultrapulse S Series Co2 Surgical Lasers Model C And L	K974789	FDA 510(k)	Class II	Active
M22 and ResurFx Systems	K170060	FDA 510(k)	Class II	Active
Modified Versapulse Select Single Wavelength, Ho: Yag And Dual Wavelength, Ho: Yag/Nd: Yag Surgical Lasers And Delivery	K990947	FDA 510(k)	Class II	Active
Novus Spectra	K022327	FDA 510(k)	Class II	Active
Selecta 7000 Frequency Doubled, Q-Switched Nd:yag Ophthalmic Laser	K004006	FDA 510(k)	Class II	Active
Lumenis Family Of Ultrapulse Surgitouch Co2 Surgical Lasers	K030147	FDA 510(k)	Class II	Active
Coherent Versapulse 2.1u /1.06u Compact Surgical Laser, Models A & B	K933318	FDA 510(k)	Class II	Active
Lumenis 1000 Integrated Slit Lamp	K052129	FDA 510(k)	Class II	Active
AcuPulse CO2 Laser System, Delivery Devices and Accessories	K212703	FDA 510(k)	Class II	Active
Model 900s Intraocular Probe	K812219	FDA 510(k)	Class II	Active
Coherent Holmium:yag Surgical Laser	K895518	FDA 510(k)	Class II	Active
Novus Varia Ophthalmic Laser And Delivery Devices With Accessories	K022181	FDA 510(k)	Class II	Active
Bclear	K020591	FDA 510(k)	Class II	Active
Coherent Laserlink Z-1000 Slit Lamp Laser Delivery Adapter	K000498	FDA 510(k)	Class II	Active
Lumenis Smart532 Laser System	K151109	FDA 510(k)	Class II	Active
Lightsheer Duet Laser System	K053628	FDA 510(k)	Class II	Active
Lumenis One Family Of Systems; Lumenis One.	K060448	FDA 510(k)	Class II	Active

Related Companies

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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