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Lumenis

Last updated May 23, 2026

Information

Country: US
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Catalogue (577)

Page 1 of 12

Device	Model / Reference	Registries	Class	Status
Slimline SIS 1000 Fiber	Slimline SIS 1000 Fiber	FDA UDI	Class II	Active
UltraPulse™ DUO	UltraPulse™ DUO	FDA UDI	Class II	Active
Lumenis Pulse P120 30 Amp	Lumenis Pulse P120 30 Amp	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 40 to 40AES-A	AcuPulse™ Upgrade Kit 40 to 40AES-A	FDA UDI	Class II	Active
AcuSpot	AcuSpot 712 Z Micromanipulator	FDA UDI	Class II	Active
Stellar M22 640 nm filter	Stellar M22 640 nm filter	FDA UDI	Class II	Unknown
Stellar M22 695 nm filter	Stellar M22 695 nm filter	FDA UDI	Class II	Unknown
High-Speed (HS) Disposables KIT	High-Speed (HS) Disposables KIT	FDA UDI	Class II	Unknown
SurgiTouch™ Scanner	Upgrade kit for AcuPulse 30/40 ST	FDA UDI	Class II	Active
SurgiTouch™ Scanning Handpiece 200mm	SurgiTouch™ Scanning Handpiece 200mm	FDA UDI	Class II	Unknown
Opti-Tip Treatment Kit	Opti-Tip Treatment Kit	FDA UDI	Class II	Unknown
SurgiTouch™ Upgrade kit for UltraPulse®	Kit for up to 007-xxxx system, 110V CPG	FDA UDI	Class II	Active
VersaPulse PowerSuite 80/100W	VersaPulse PowerSuite 80/100W	FDA UDI	Class II	Active
Digital AcuBlade™ for UltraPulse® SurgiTouch™	Digital AcuBlade™ for UltraPulse® SurgiTouch™	FDA UDI	Class II	Active
Lumenis 1000 Integrated Slit Lamp	Lumenis 1000 Integrated Slit Lamp	FDA UDI	Class II	Unknown
FemTouch™ Fine Focus Disposable Tips	FemTouch™ Fine Focus Disposable Tips	FDA UDI	Class II	Unknown
M22™	M22	FDA UDI	Class II	Unknown
HoLEP Kit with non-SIS fiber for VersaCut	HoLEP Kit with non-SIS fiber for VersaCut	FDA UDI	Class II	Active
Stellar M22 615 nm filter	Stellar M22 615 nm filter	FDA UDI	Class II	Unknown
Sapphaire Light Guide Set	Sapphaire Light Guide Set	FDA UDI	Class II	Unknown
UltraPulse α	O.R.	FDA UDI	Class II	Unknown
UltraPulse® DUO	UltraPulse DUO	FDA UDI	Class II	Active
VersaPulse PowerSuite 30W	VersaPulse PowerSuite 30W	FDA UDI	Class II	Active
Q-Switch Nd:YAG Metal Treatment Tip 8 mm	Q-Switch Nd:YAG Metal Treatment Tip 8 mm	FDA UDI	Class II	Unknown
Lumenis Pulse 100H	Lumenis Pulse 100H	FDA UDI	Class II	Active
Slimline Endo 550 Fiber	Slimline Endo 550 Fiber	FDA UDI	Class II	Active
VersaPulse P20	VERSAPULSE P20	FDA UDI	Class II	Active
AcuPulse™ DUO	AcuPulse™ DUO	FDA UDI	Class II	Active
VersaCut+ Sterile Outer Blade	VersaCut+ Sterile Outer Blade	FDA UDI	Class II	Active
Universal IPL Acne Expert Filter	Universal IPL Acne Expert Filter	FDA UDI	Class II	Unknown
OtoLase™ Starter Kit	OtoLase™ Starter Kit	FDA UDI	Class II	Active
MicroSlad™ 717/718 Lens Slide 350 mm	19109	FDA UDI	Class II	Active
Nasal Probe Straight Tip 90 Degree Right Mirror	14632	FDA UDI	Class II	Active
Stellar SapphireCool LG 8x15	Stellar SapphireCool LG 8x15	FDA UDI	Class II	Unknown
Acculite EndoOcular	Standard, 20ga 20° bend, SMA 906, 200µm	FDA UDI	Class II	Unknown
Nezhat™ Optical Coupler for Single Puncture Laparoscopes (F300 mm)	Nezhat™ Optical Coupler for Single Puncture Laparoscopes (F300 mm)	FDA UDI	Class II	Active
OptiLight™	OptiLight™	FDA UDI	Class II	Unknown
Fixed Eye Safety Filter	Fixed Eye Safety Filter	FDA UDI	Class II	Unknown
MicroSlad™ 719 Lens Slide 275 mm	19119	FDA UDI	Class II	Active
FemTouch™	FemTouch™	FDA UDI	Class II	Unknown
UltraPulse® Focused Incisional Handpiece Set	UltraPulse® Focused Incisional Handpiece Set	FDA UDI	Class II	Unknown
AcuPulse™ Combo & StretchTouch Modes UG	AcuPulse™ Combo & StretchTouch Modes UG	FDA UDI	Class II	Active
SurgiTouch™ Scanner	kit for AcuPulse and AcuPulse DUO	FDA UDI	Class II	Unknown
Fixed Eye Safety Filter	Fixed Eye Safety Filter	FDA UDI	Class II	Unknown
Stellar™ M22	Stellar LMX, AES	FDA UDI	Class II	Unknown
SlimLine™	SlimLine™ SIS EZ 365 LP	FDA UDI	Class II	Active
Moses™	Moses™ 550 D/F/L LP	FDA UDI	Class II	Active
VersaPulse PowerSuite	VersaPulse PowerSuite 60W	FDA UDI	Class II	Active
AcuPulse™ W	AcuPulse™ W	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

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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.

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