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Lumenis

Last updated May 23, 2026

Information

Country: US
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Catalogue (577)

Page 3 of 12

Device	Model / Reference	Registries	Class	Status
ResurFX	ResurFX	FDA UDI	Class II	Unknown
ENDURE™ sterilization tray	ENDURE™ sterilization tray	FDA UDI	Class II	Active
Universal IPL 590 nm Expert Filter	Universal IPL 590 nm Expert Filter	FDA UDI	Class II	Unknown
Slimline Endo SIS 200 Fiber	Slimline Endo SIS 200 Fiber	FDA UDI	Class II	Active
LaserLink Z	LaserLink Z	FDA UDI	Class II	Unknown
Slimline Endo SIS 550 Fiber	Slimline Endo SIS 550 Fiber	FDA UDI	Class II	Active
FemTouch™ Plane Tip	FemTouch™ Plane Tip	FDA UDI	Class II	Unknown
Slimline 550 Fiber	Slimline 550 Fiber	FDA UDI	Class II	Active
SurgiTouch Scanner	kit for UltraPulse/UltraPulse DUO	FDA UDI	Class II	Unknown
Slimline EZ 365 Fiber	Slimline EZ 365 Fiber	FDA UDI	Class II	Active
SS FiberLase™ Handpiece Rigid Kit	SS FiberLase™ Handpiece Rigid Kit	FDA UDI	Class II	Active
Slimline GI SIS 365 Fiber	Slimline GI SIS 365 Fiber	FDA UDI	Class II	Active
Digital AcuBlade Upgrade Kit	Digital AcuBlade Upgrade Kit	FDA UDI	Class II	Active
MicroLase™ Fiber	MicroLase™ Fiber	FDA UDI	Class II	Active
AcuPulse™ Upgrade Kit to AES-A 4 Modes Upgrade	AcuPulse™ Upgrade Kit to AES-A 4 Modes Upgrade	FDA UDI	Class II	Active
Q-Switch Nd:YAG Disposable Tips Spot Size 2.5 mm	Q-Switch Nd:YAG Disposable Tips Spot Size 2.5 mm	FDA UDI	Class II	Unknown
OptiLight IPL Module Kit	OptiLight IPL Module Kit	FDA UDI	Class II	Unknown
Smart532	Smart532	FDA UDI	Class II	Unknown
FiberLase™ CO2 Fiber	FiberLase™ CO2 Fiber	FDA UDI	Class II	Active
SlimLine™	SlimLine™ SIS 550 LP	FDA UDI	Class II	Active
Xplume Smoke Evacuator	Xplume Smoke Evacuator	FDA UDI	Class II	Active
SapphireCool Light Guide 2 x 4 mm	SapphireCool Light Guide 2 x 4 mm	FDA UDI	Class II	Unknown
Stellar SapphireCool LG 6mm	Stellar SapphireCool LG 6mm	FDA UDI	Class II	Unknown
DeepFX™ Microscanner Kit	Kit for System up to 008-xxxx	FDA UDI	Class II	Unknown
FiberLase™ HP-R 60 mm straight, curved tip	FiberLase™ HP-R 60 mm straight, curved tip	FDA UDI	Class II	Active
VersaPulse PowerSuite 80/100W	VersaPulse PowerSuite 80/100W	FDA UDI	Class II	Active
SurgiTouch™ Scanner	Kit for UltraPulse SurgiTouch	FDA UDI	Class II	Active
Multi-spot Nd:YAG Treatment Head	Multi-spot Nd:YAG Treatment Head	FDA UDI	Class II	Unknown
M22 ResurFX Module	M22 ResurFX Module	FDA UDI	Class II	Unknown
Fixed Eye Safety Filter	Fixed Eye Safety Filter	FDA UDI	Class II	Unknown
Q-Switch Nd:YAG Disposable Tips Spot Size 3.5 mm	Q-Switch Nd:YAG Disposable Tips Spot Size 3.5 mm	FDA UDI	Class II	Unknown
SS FiberLase™ HP-R 180 mm straight, straight tip	SS FiberLase™ HP-R 180 mm straight, straight tip	FDA UDI	Class II	Active
MicroSlad™ 717/718 Lens Slide 275 mm	19120	FDA UDI	Class II	Active
Q-Switched Nd:YAG Treatment Head	Q-Switched Nd:YAG Treatment Head	FDA UDI	Class II	Unknown
LightSheer Infinity UHP 1060	LightSheer Infinity UHP 1060	FDA UDI	Class II	Unknown
UltraPulse® α	Office	FDA UDI	Class II	Unknown
Xplume 9615 Smoke Evacuation Autoclavable Plastic Funnel Set	Xplume 9615 Smoke Evacuation Autoclavable Plastic Funnel Set	FDA UDI	Class II	Active
Stellar Optima Treatment Kit	Stellar Optima Treatment Kit	FDA UDI	Class II	Unknown
UltraPulse® SurgiTouch™	Office	FDA UDI	Class II	Unknown
LightSheer Desire ET Handpiece	LightSheer Desire ET Handpiece	FDA UDI	Class II	Unknown
OtoLase™ Curved Tip	OtoLase™ Curved Tip	FDA UDI	Class II	Active
VersaCut Handpiece	VersaCut Handpiece	FDA UDI	Class II	Active
VersaPulse PowerSuite 80/100W	VersaPulse PowerSuite 80/100W	FDA UDI	Class II	Active
Slimline Endo 200 Fiber	Slimline Endo 200 Fiber	FDA UDI	Class II	Active
Q-Switch Nd:YAG Metal Treatment Tip 2.5 mm	Q-Switch Nd:YAG Metal Treatment Tip 2.5 mm	FDA UDI	Class II	Unknown
Fixed Eye Safety Filter	Fixed Eye Safety Filter	FDA UDI	Class II	Unknown
Acculite EndoOcular	Standard, 20ga str taper, SmartScan, 200µm	FDA UDI	Class II	Unknown
Smart LIO	NA	FDA UDI	Class II	Unknown
M22 Q-Switch Lens Assembly & 6mm Metal Treatment Tip Kit	M22 Q-Switch Lens Assembly & 6mm Metal Treatment Tip Kit	FDA UDI	Class II	Unknown
Slimline 365 Fiber	Slimline 365 Fiber	FDA UDI	Class II	Active

Related Companies

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Authorities

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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