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Lumenis

Last updated May 23, 2026

Information

Country: US
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Catalogue (577)

Page 5 of 12

Device	Model / Reference	Registries	Class	Status
Stellar M22 560 nm filter	Stellar M22 560 nm filter	FDA UDI	Class II	Unknown
UltraPulse® Encore™	O.R.	FDA UDI	Class II	Unknown
MicroSlad™ micromanipulator side-entry port	MicroSlad™ micromanipulator side-entry port	FDA UDI	Class II	Active
Digital AcuBlade™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for 008-xxxx and above, 220V	FDA UDI	Class II	Active
Universal IPL 615 nm Expert Filter	Universal IPL 615 nm Expert Filter (Set 4)	FDA UDI	Class II	Unknown
LightSheer Desire XC 1060 Handpiece	LightSheer Desire XC 1060 Handpiece	FDA UDI	Class II	Unknown
Fiber Inserts	14620	FDA UDI	Class II	Active
UltraScan CPG	UltraScan CPG	FDA UDI	Class II	Unknown
Xplume 9616 Smoke Evacuation 22mm x 6mm Plastic Reducer Fitting Set	Xplume 9616 Smoke Evacuation 22mm x 6mm Plastic Reducer Fitting Set	FDA UDI	Class II	Active
Universal IPL SapphireCool Light Guide set	Universal IPL SapphireCool Light Guide set	FDA UDI	Class II	Unknown
OtoLase™ Curved HP	OtoLase™ Curved HP	FDA UDI	Class II	Active
UltraPulse® SurgiTouch™ Upgrade Kit	UltraPulse® SurgiTouch™ Upgrade Kit	FDA UDI	Class II	Active
SapphireCool Light Guide 15 × 35 mm	SapphireCool Light Guide 15 × 35 mm	FDA UDI	Class II	Unknown
Slimline Sterilization Tray	Slimline Sterilization Tray	FDA UDI	Class II	Active
Acculite EndoOcular	Illum/Lg Plug, 20ga 45°, SMA 906, 200µm	FDA UDI	Class II	Unknown
OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™	Kit for 008-xxxx and above, 200V PAL	FDA UDI	Class II	Active
Selecta Duet	Selecta Duet	FDA UDI	Class II	Unknown
Laryngeal Probe Straight Tip, 90 Degree Right Mirror Smoke Evacuation Channel	14733	FDA UDI	Class II	Active
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for up to 007-xxxx, 110V	FDA UDI	Class II	Unknown
SlimLine™	SlimLine™ SIS 365	FDA UDI	Class II	Active
Automatic Eye Safety Filter	Automatic Eye Safety Filter	FDA UDI	Class II	Unknown
Lumenis Pulse 60H	Lumenis Pulse 60H, 60Hz	FDA UDI	Class II	Active
FemTouch™ Fine Focus Tip	FemTouch™ Fine Focus Tip	FDA UDI	Class II	Unknown
MicroSlad™ 717/718 Lens Slide 200 mm	19106	FDA UDI	Class II	Active
Lumenis Pulse 30H	Lumenis Pulse 30H	FDA UDI	Class II	Active
Q-Switch Nd:YAG Metal Treatment Tip 5 mm	Q-Switch Nd:YAG Metal Treatment Tip 5 mm	FDA UDI	Class II	Unknown
FiberLase™ HP-M 300 mm malleable	FiberLase™ HP-M 300 mm malleable	FDA UDI	Class II	Active
SS FiberLase™ HP-R 240 mm bent, straight tip	SS FiberLase™ HP-R 240 mm bent, straight tip	FDA UDI	Class II	Active
LightSheer Duet HS Handpiece	LightSheer Duet HS Handpiece	FDA UDI	Class II	Unknown
Acculite EndoOcular	Illum/Sm Plug, 20ga 45°, SMA 906, 200µm	FDA UDI	Class II	Unknown
Rosacea IV-V Filter	Rosacea IV-V Filter	FDA UDI	Class II	Active
AcuPulse 40WG	AcuPulse 40WG	FDA UDI	Class II	Active
Smart-V Illumination Add-on	Smart-V Illumination Add-on	FDA UDI	Class II	Unknown
Stellar M22 Universal IPL kit	Stellar M22 Universal IPL kit	FDA UDI	Class II	Unknown
LightSheer Desire XC Handpiece	LightSheer Desire XC Handpiece	FDA UDI	Class II	Unknown
Lumenis Pulse 120H	Lumenis Pulse 120H	FDA UDI	Class II	Active
Universal IPL 560 nm Expert Filter	Universal IPL 560 nm Expert Filter (Set 4)	FDA UDI	Class II	Unknown
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for 008-xxxx and above, 110V CPG	FDA UDI	Class II	Active
Universal IPL 695 nm Expert Filter	Universal IPL 695 nm Expert Filter (Set 4)	FDA UDI	Class II	Unknown
Acculite™ EndoOcular®	Aspirating, 20ga str, SMA 906, 200µm	FDA UDI	Class II	Unknown
Xplume 9610 Smoke Evacuation Primary Filter Set	Xplume 9610 Smoke Evacuation Primary Filter Set	FDA UDI	Class II	Active
MicroSlad™ 717/718 Lens Slide 400 mm	19110	FDA UDI	Class II	Active
SlimLine™ 200 D/F/L LP	SlimLine™ 200 D/F/L LP	FDA UDI	Class II	Active
Xplume 9613 Smoke Evacuation 6 mm x 2 ft Silicone Tubing Set	Xplume 9613 Smoke Evacuation 6 mm x 2 ft Silicone Tubing Set	FDA UDI	Class II	Active
Lumenis Pulse 120H	Lumenis Pulse 120H	FDA UDI	Class II	Active
Xplume Smoke Evacuator	With Vacuum Tubing	FDA UDI	Class II	Active
ColpoSlad 725 Micromanipulator	ColpoSlad 725 Micromanipulator	FDA UDI	Class II	Active
Acculite EndoOto	Horn, 24ga 20° Angled, SMA 906, 200µm	FDA UDI	Class II	Unknown
Versacut Tissue Morcellator	Versacut Tissue Morcellator	FDA UDI	Class II	Active
Stellar M22 Q-switched Nd:YAG upgrade	Q-switched Nd:YAG upgrade	FDA UDI	Class II	Unknown

Related Companies

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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