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Lumenis

Last updated May 23, 2026

Information

Country: US
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Catalogue (577)

Page 2 of 12

Device	Model / Reference	Registries	Class	Status
SS FiberLase™ HP-M 240 mm malleable	SS FiberLase™ HP-M 240 mm malleable	FDA UDI	Class II	Active
MicroSlad™ Lens Slide 300 mm	19103	FDA UDI	Class II	Active
OtoLase™ Straight Tip	OtoLase™ Straight Tip	FDA UDI	Class II	Active
Slimline SIS 200 Fiber	Slimline SIS 200 Fiber	FDA UDI	Class II	Active
Universal IPL 515 nm Expert Filter	Universal IPL 515 nm Expert Filter	FDA UDI	Class II	Unknown
LaserLink S	LaserLink S	FDA UDI	Class II	Unknown
SurgiTouch™ Scanning Handpiece Set	SurgiTouch™ Scanning Handpiece Set	FDA UDI	Class II	Unknown
SurgiTouch Scanner	SurgiTouch Scanner	FDA UDI	Class II	Unknown
FemTouch™ Standard Focus Tip	FemTouch™ Standard Focus Tip	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
SlimLine™	SlimLine™ SIS 550	FDA UDI	Class II	Active
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for up to 007-xxxx, 110V	FDA UDI	Class II	Active
Slimline EZ SIS 550 Fiber	Slimline EZ SIS 550 Fiber	FDA UDI	Class II	Active
Digital Duet	Selecta Duet Digital	FDA UDI	Class II	Unknown
Nezhat™ Optical Coupler for Single Puncture Laparoscopes (F300 mm)	Nezhat Coupler and Adaptors	FDA UDI	Class II	Active
Digital AcuBlade™ Upgrade kit for UltraPulse® SurgiTouch™	Digital AcuBlade™ Upgrade kit for UltraPulse® SurgiTouch™	FDA UDI	Class II	Active
MicroSlad™ 715 Micromanipulator	MicroSlad™ 715 Micromanipulator	FDA UDI	Class II	Active
Novus Spectra	Novus Spectra	FDA UDI	Class II	Unknown
SapphireCool Light Guide 9 mm	SapphireCool Light Guide 9 mm	FDA UDI	Class II	Unknown
Smart LIO	NA	FDA UDI	Class II	Unknown
SS FiberLase™ HP-R 140 mm straight, curved tip	SS FiberLase™ HP-R 140 mm straight, curved tip	FDA UDI	Class II	Active
VersaPulse PowerSuite	VersaPulse PowerSuite 100W	FDA UDI	Class II	Active
FiberLase™ Accessory Starter Kit with Endure Fiber	FiberLase™ Accessory Starter Kit with Endure Fiber	FDA UDI	Class II	Active
Slimline 200 Fiber	Slimline 200 Fiber	FDA UDI	Class II	Active
OPT Handpiece	OPT Handpiece	FDA UDI	Class II	Unknown
Lumenis Pulse 30H	Lumenis Pulse 30H	FDA UDI	Class II	Active
Acculite™ EndoOcular®	" Aspirat., 20ga 45° bend, SMA 906, 200µm"	FDA UDI	Class II	Unknown
SlimLine™	Slimline™ EZ SIS 200	FDA UDI	Class II	Active
VersaCut™	VersaCut™	FDA UDI	Class II	Active
FiberLase™ HP-R 60mm straight, straight tip	FiberLase™ HP-R 60mm straight, straight tip	FDA UDI	Class II	Active
FiberLase™ HP-R 180 mm straight, curved tip	FiberLase™ HP-R 180 mm straight, curved tip	FDA UDI	Class II	Active
ResurFX SapphireCool Tip	ResurFX SapphireCool Tip	FDA UDI	Class II	Unknown
Nasal Probe Bent Tip Smoke Evacuation Channel	14640	FDA UDI	Class II	Active
UltraPulse® Focused Incisional Handpiece Set	UltraPulse® Focused Incisional Handpiece Set	FDA UDI	Class II	Active
AcuPulse™ 40WG	AcuPulse™ 40WG	FDA UDI	Class II	Active
Moses™	Moses™ 365 D\F\L	FDA UDI	Class II	Active
SS FiberLase™ Accessory Starter Kit with FiberLase Fiber	SS FiberLase™ Accessory Starter Kit with FiberLase Fiber	FDA UDI	Class II	Active
Lumenis Pulse 100H	Lumenis Pulse 100H	FDA UDI	Class II	Active
Array LaserLink	Array LaserLink	FDA UDI	Class II	Unknown
Digital AcuBlade™ Upgrade kit for AcuPulse™	Kit for AB09	FDA UDI	Class II	Active
OptiLight IPL Handpiece NF	OptiLight IPL Handpiece NF	FDA UDI	Class II	Unknown
Automatic Eye Safety Filter	Automatic Eye Safety Filter	FDA UDI	Class II	Unknown
LIO Keeler	LIO Keeler	FDA UDI	Class II	Unknown
LightSheer Infinity LR (9x27) Adaptor	LightSheer Infinity LR (9x27) Adaptor	FDA UDI	Class II	Unknown
Stellar M22 Acne filter	Stellar M22 Acne filter	FDA UDI	Class II	Unknown
AcuPulse™ Incisional Handpiece 125 mm	AcuPulse™ Incisional Handpiece 125 mm	FDA UDI	Class II	Unknown
MicroSlad™ 719 Lens Slide 400 mm	19105	FDA UDI	Class II	Active
Q-Switched Nd:YAG Upgrade Kit	Q-Switched Nd:YAG Upgrade Kit	FDA UDI	Class II	Unknown
Smart LIO	NA	FDA UDI	Class II	Unknown
VersaCut+ Tissue Morcellator with Inverted Handpiece	VersaCut+ Tissue Morcellator with Inverted Handpiece	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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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