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Lumenis

Last updated May 23, 2026

Information

Country: US
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Catalogue (577)

Page 10 of 12

Device	Model / Reference	Registries	Class	Status
Automatic Eye Safety Filter	Automatic Eye Safety Filter	FDA UDI	Class II	Unknown
VersaPulse PowerSuite 100W	VersaPulse PowerSuite 100W	FDA UDI	Class II	Active
Slimline Endo 365 Fiber	Slimline Endo 365 Fiber	FDA UDI	Class II	Active
FiberLase™ Small Sterilization Tray	FiberLase™ Small Sterilization Tray	FDA UDI	Class II	Active
Q-Switch Nd:YAG Disposable Tips Spot Size 5 mm	Q-Switch Nd:YAG Disposable Tips Spot Size 5 mm	FDA UDI	Class II	Unknown
Acculite EndoOcular	Illum/Sm Plug, 20ga str, SMA 906, 200µm	FDA UDI	Class II	Unknown
VersaPulse P20	VersaPulse P20	FDA UDI	Class II	Active
SapphireCool Light Guide 6 mm	SapphireCool Light Guide 6 mm	FDA UDI	Class II	Unknown
Stellar SapphireCool LG 15x35	Stellar SapphireCool LG 15x35	FDA UDI	Class II	Unknown
Lumenis Pulse 120H	Lumenis Pulse 120H	FDA UDI	Class II	Active
Lumenis Pulse 50H	Lumenis Pulse 50H	FDA UDI	Class II	Active
Acculite EndoOto	24ga 15° Angled, SMA 905, 200µm	FDA UDI	Class II	Unknown
MicroSwitch Joystick	MicroSwitch Joystick	FDA UDI	Class II	Active
SS FiberLase™ HP-R 60 mm straight, curved tip	SS FiberLase™ HP-R 60 mm straight, curved tip	FDA UDI	Class II	Active
Laryngeal Probe Straight Tip 90 Degree Left Mirror Smoke Evacuation Channel	14734	FDA UDI	Class II	Active
Acculite EndoOcular	Standard, 20ga str taper, SMA 906, 200um	FDA UDI	Class II	Unknown
MicroSlad™ 717/718 Lens Slide 300 mm	19108	FDA UDI	Class II	Active
Lumenis Pulse, Moses 2.0 (DOM)	Lumenis Pulse, Moses 2.0 (DOM)	FDA UDI	Class II	Active
UltraPulse® Encore™	Office	FDA UDI	Class II	Unknown
Multi-Application Handpiece Set 120° Mirror Tip	Multi-Application Handpiece Set 120° Mirror Tip	FDA UDI	Class II	Unknown
OtoScan™ Ear Aeration System	NTSC camera	FDA UDI	Class II	Active
Lumenis Pulse 60H, 50Hz	Lumenis Pulse 60H, 50Hz	FDA UDI	Class II	Active
Acculite EndoOcular	Standard, 20ga str taper, SMA 905, 200µm	FDA UDI	Class II	Unknown
Laryngeal Probe Straight Tip Smoke Evacuation Channel	14732	FDA UDI	Class II	Active
FiberLase™ HP-M 240 mm malleable	FiberLase™ HP-M 240 mm malleable	FDA UDI	Class II	Active
Slimline SIS 365 Fiber	Slimline SIS 365 Fiber	FDA UDI	Class II	Active
LightSheer Duet ET Handpiece	LightSheer Duet ET Handpiece	FDA UDI	Class II	Unknown
Lumenis Pulse, Moses 2.0 (INT)	Lumenis Pulse, Moses 2.0 (INT)	FDA UDI	Class II	Active
SlimLine™ SIS EZ 200 LP	SlimLine™ SIS EZ 200 LP	FDA UDI	Class II	Active
ResurFX Precision Tip	ResurFX Precision Tip	FDA UDI	Class II	Unknown
SS FiberLase™ Handpiece-M Kit	SS FiberLase™ Handpiece-M Kit	FDA UDI	Class II	Active
DeepFX™ Microscanner	DeepFX™ Microscanner	FDA UDI	Class II	Unknown
STC CO2 Fiber	STC CO2 Fiber	FDA UDI	Class II	Active
Digital AcuBlade™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for up to 007-xxxx, 110V	FDA UDI	Class II	Active
Universal IPL 695 nm Expert Filter	Universal IPL 695 nm Expert Filter	FDA UDI	Class II	Unknown
Lumenis Pulse 60H	Lumenis Pulse 60H, 50Hz	FDA UDI	Class II	Active
Lumenis Pulse 30H	Lumenis Pulse 30H	FDA UDI	Class II	Active
Xplume 9617 Smoke Evacuation 22 mm I.D. x 6 ft Plastic Hose Set	Xplume 9617 Smoke Evacuation 22 mm I.D. x 6 ft Plastic Hose Set	FDA UDI	Class II	Active
FiberLase™ Endoscope Protection Sheath	FiberLase™ Endoscope Protection Sheath	FDA UDI	Class II	Active
TrueSpot™ 2mm Handpiece	TrueSpot™ 2mm Handpiece	FDA UDI	Class II	Unknown
MicroSlad™ 719 Lens Slide 350 mm	19104	FDA UDI	Class II	Active
MicroSlad™ 719 Lens Slide 250 mm	19102	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 40AES-F to 40AES-R	AcuPulse™ Upgrade Kit 40AES-F to 40AES-R	FDA UDI	Class II	Unknown
MicroSlad™ 719 Lens Slide 275 mm	19119	FDA UDI	Class II	Active
FiberLase™ HP-R 240 mm bent, curved tip	FiberLase™ HP-R 240 mm bent, curved tip	FDA UDI	Class II	Active
SS FiberLase™ HP-R 140 mm bent, straight tip	SS FiberLase™ HP-R 140 mm bent, straight tip	FDA UDI	Class II	Active
AcuScan™ 120 Microscanner Upgrade Kit	AcuScan™ 120 Microscanner Upgrade Kit	FDA UDI	Class II	Unknown
UltraScan™ CPG	UltraScan™ CPG	FDA UDI	Class II	Unknown
FiberLase™ HP-R 140 mm bent, straight tip	FiberLase™ HP-R 140 mm bent, straight tip	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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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