Manufacturer

Lumenis

Germany, Israel, United StatesLegal entities : LUMENIS LTD, Lumenis (Germany) GmbH, Lumenis Be Inc

Markets : Austria · Belgium · Bulgaria · Cyprus · France · Germany · Italy · Netherlands · Poland · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 84 · PMA : 2 · class I, II, III · latest in 2026 · see on the FDA website

EU representative : Lumenis (Germany) GmbH (Germany)

Website info.germany@lumenis.com

8 categories, 35 models including 35 on the market, 3 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Laser surgery instruments - hardware accessories	Z12011080	AcuPulse Incisional Handpiece 125mm AcuPulse Upgrade Kit 40 to 40AES-R3 refs AcuPulse Upgrade Kit 40AES-F to 40AES-R AcuPulse™ Incisional HP 125mm3 refs Alpha CPG2 refs 7 others DeepFX™ Air Disposable Tips2 refs FemTouch™ Adaptor Kit2 refs FemTouch™ Fine Focus Disposable Tip3 refs FemTouch™ Fine Focus Tip3 refs FemX™ Disposable Tips Focused Incisional HP 0.2mm and 1.02 refs TrueSpot collimated 2.0mm Handpiece2 refs	I, IIa, IIb MDR	EUDAMED record Report an error
Multi-platform laser	Z12011019	Digital OptiLight System2 refs IPL Upgrade Kit for OptiLight2 refs M22TM Q-Switched Head3 refs Multi-SpotTM Nd:YAG Head3 refs OPT Handpiece3 refs 5 others Opti-Tip Master Pack3 refs OptiLight Filter2 refs Refurbish M22 ResurFX Module Upgrade Kit3 refs ResurFXTM Head Stellar M22 RFX3 refs	IIb MDR	EUDAMED record Report an error
Carbon dioxide surgical laser	Z12011005	AcuPulse™2 refs Alpha CPG2 refs UltraPulse® α2 refs	IIb MDR	EUDAMED record Report an error
Erbium surgical laser	Z12011014	FoLiCool Tip2 refs FoLix System2 refs FoLix™ Handpiece2 refs	IIb MDR	EUDAMED record Report an error
Laser surgery instruments - other	Z12011099	Digital Duet TM3 refs LaserLink S Kit3 refs Smart-V Illumination Add-on Kit KT-2008059BE	I, IIb MDR	EUDAMED record Report an error
Holmium surgical laser	Z12011003	MOSES Raydar™ Pulse™ Pulse 120H3 refs	IIb MDR	EUDAMED record Report an error
Diode surgical laser	Z12011016	LightSheer® QUATTRO™2 refs	IIb MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - other	Z129099	High-Speed (HS) Disposables Kit	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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