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Lumenis

Last updated May 23, 2026

Information

Country: US
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Catalogue (577)

Page 9 of 12

Device	Model / Reference	Registries	Class	Status
MicroSlad™ 719 Lens Slide 200 mm	19101	FDA UDI	Class II	Active
VersaCut™	Steralization Tray	FDA UDI	Class II	Active
SlimLine™	Slimline™ EZ SIS 365	FDA UDI	Class II	Active
DeepFX™ Microscanner	DeepFX™ Microscanner	FDA UDI	Class II	Unknown
Multi-Spot Nd:YAG lightguide 1.5 mm	Multi-Spot Nd:YAG lightguide 1.5 mm	FDA UDI	Class II	Unknown
Lumenis Pulse 100H	Lumenis Pulse 100H	FDA UDI	Class II	Active
IPL Upgrade Kit for Stellar Optima	IPL Upgrade Kit for Stellar Optima	FDA UDI	Class II	Unknown
MicroSlad™ 717/718 Lens Slide 250 mm	19107	FDA UDI	Class II	Active
SlimLine™	SlimLine™ SIS 365 LP	FDA UDI	Class II	Active
Lumenis Pulse 30H	Lumenis Pulse 30H	FDA UDI	Class II	Active
Lumenis Pulse 120H	Lumenis Pulse Moses 2.0 (DOM)	FDA UDI	Class II	Active
Fixed Eye Safety Filter	Fixed Eye Safety Filter	FDA UDI	Class II	Unknown
BeamAlign Laparoscope Coupler 200mm	BeamAlign Laparoscope Coupler 200mm	FDA UDI	Class II	Active
Q-Switch Lens Assembly	Q-Switch Lens Assembly	FDA UDI	Class II	Unknown
Nasal Probe Straight Tip Smoke Evacuation Channel	14634	FDA UDI	Class II	Active
SS FiberLase™ HP-R 60mm straight, straight tip	SS FiberLase™ HP-R 60mm straight, straight tip	FDA UDI	Class II	Active
AcuPulse™ DUO	AcuPulse™ DUO	FDA UDI	Class II	Active
SurgiTouch™ Scanner	kit for UltraPulse/UltraPulse DUO	FDA UDI	Class II	Active
SS FiberLase™ HP-R 180 mm straight, curved tip	SS FiberLase™ HP-R 180 mm straight, curved tip	FDA UDI	Class II	Active
Xpeeda DSL Fiber	Xpeeda DSL Fiber	FDA UDI	Class II	Active
SurgiTouch™ Upgrade kit for UltraPulse®	Kit for up to 007-xxxx, 220V CPG	FDA UDI	Class II	Unknown
FiberLase™ ENDURE CO2 Fiber	FiberLase™ ENDURE CO2 Fiber	FDA UDI	Class II	Active
Vanilla to OptiLight Upgrade Kit	Vanilla to OptiLight Upgrade Kit	FDA UDI	Class II	Active
AcuScan™ 120 Upgrade Kit	AcuScan™ 120 Upgrade Kit	FDA UDI	Class II	Unknown
VersaCut+ Tissue Morcellator with Regular Handpiece	VersaCut+ Tissue Morcellator with Regular Handpiece	FDA UDI	Class II	Active
ResurFX Handpiece	ResurFX Handpiece	FDA UDI	Class II	Unknown
AcuSpot	AcuSpot 712 L Micromanipulator	FDA UDI	Class II	Active
Slimline Endo SIS 365 Fiber	Slimline Endo SIS 365 Fiber	FDA UDI	Class II	Active
SlimLine™	SlimLine™ SIS EZ 550	FDA UDI	Class II	Active
AcuPulse™ Upgrade Kit 40AES-F to 40AES-A	AcuPulse™ Upgrade Kit 40AES-F to 40AES-A	FDA UDI	Class II	Active
VersaPulse PowerSuite 100W	VersaPulse PowerSuite 100W	FDA UDI	Class II	Active
Universal IPL 615 nm Expert Filter	Universal IPL 615 nm Expert Filter	FDA UDI	Class II	Unknown
SlimLine™	SlimLine™ SIS 200	FDA UDI	Class II	Active
OtoLase™ Curved Tip Package	OtoLase™ Curved Tip Package	FDA UDI	Class II	Active
Versapulse P20	VersaPulse P20	FDA UDI	Class II	Active
Xplume 9614 Smoke Evacuation Autoclavable Plastic Wand Set	Xplume 9614 Smoke Evacuation Autoclavable Plastic Wand Set	FDA UDI	Class II	Active
AcuPulse™	AcuPulse	FDA UDI	Class II	Unknown
VersaPulse PowerSuite	VersaPulse PowerSuite 100W	FDA UDI	Class II	Active
VersaPulse Powersuite	VersaPulse Powersuite 80/100W	FDA UDI	Class II	Active
SurgiTouch™ Upgrade kit for UltraPulse®	Kit for up to 007-xxxx, 220V	FDA UDI	Class II	Unknown
Lumenis Pulse 30H	Lumenis Pulse 30H	FDA UDI	Class II	Active
Lumenis Pulse 120H	Lumenis Pulse 120H	FDA UDI	Class II	Active
SurgiTouch Scanner	Upgrade kit for AcuPulse 30/40 to 30/40 ST	FDA UDI	Class II	Active
Lumenis Pulse 100H	Lumenis Pulse 100H	FDA UDI	Class II	Active
VersaCut Sterile Inner Blade	VersaCut Sterile Inner Blade	FDA UDI	Class II	Active
AcuPulse™ DUO HW Upgrade kit AcuPulse™ to DUO	Kit with prolonged arm	FDA UDI	Class II	Active
SS FiberLase™ HP-M 140 mm malleable	SS FiberLase™ HP-M 140 mm malleable	FDA UDI	Class II	Active
MicroSlad™ 719 Lens Slide 350 mm	19104	FDA UDI	Class II	Active
Q-Switch Nd:YAG Metal Treatment Tip 2 mm	Q-Switch Nd:YAG Metal Treatment Tip 2 mm	FDA UDI	Class II	Unknown
SapphireCool Light Guide 8 × 15 mm	SapphireCool Light Guide 8 × 15 mm	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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