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Lumenis

Last updated May 23, 2026

Information

Country: US
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Catalogue (577)

Page 4 of 12

Device	Model / Reference	Registries	Class	Status
AcuPulse™ DUO	AcuPulse™ DUO	FDA UDI	Class II	Active
Moses™	Moses™ 365 D/F/L LP	FDA UDI	Class II	Active
Selecta Duet	Selecta Duet	FDA UDI	Class II	Unknown
Universal IPL 755 nm Expert Filter	Universal IPL 755 nm Expert Filter (Set 4)	FDA UDI	Class II	Unknown
Lumenis Pulse 120H	Lumenis Pulse 120H	FDA UDI	Class II	Active
OtoLase™ Fiber	OtoLase™ Fiber	FDA UDI	Class II	Active
SS FiberLase™ HP-M 90 mm malleable	SS FiberLase™ HP-M 90 mm malleable	FDA UDI	Class II	Active
OtoScan™ Ear Aeration System	PAL camera	FDA UDI	Class II	Active
FiberLase™ HP-M 90 mm malleable	FiberLase™ HP-M 90 mm malleable	FDA UDI	Class II	Active
MicroSlad™ 719 Lens Slide 200 mm	19101	FDA UDI	Class II	Active
LightSheer	QUATTRO	FDA UDI	Class II	Unknown
Universal IPL 640 nm Expert Filter	Universal IPL 640 nm Expert Filter (Set 4)	FDA UDI	Class II	Unknown
Slimline EZ SIS 200 Fiber	Slimline EZ SIS 200 Fiber	FDA UDI	Class II	Active
VersaPulse PowerSuite	VersaPulse PowerSuite 60W	FDA UDI	Class II	Active
Lumenis Pulse 120H	Lumenis Pulse 120H	FDA UDI	Class II	Active
AcuPulse™ Upgrade Kit 40AES-R To 40AES-A	AcuPulse™ Upgrade Kit 40AES-R To 40AES-A	FDA UDI	Class II	Active
Nasal probe Starter Kit	14630	FDA UDI	Class II	Active
Stellar Optima™	Stellar Optima™	FDA UDI	Class II	Unknown
Stellar M22	Stellar M22	FDA UDI	Class II	Unknown
AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade	AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade	FDA UDI	Class II	Active
VersaPulse PowerSuite 60W	VersaPulse PowerSuite 60W	FDA UDI	Class II	Active
Automatic Eye Safety Filter	Automatic Eye Safety Filter	FDA UDI	Class II	Unknown
SurgiTouch™ Scanning Handpiece 125mm	SurgiTouch™ Scanning Handpiece 125mm	FDA UDI	Class II	Unknown
LightSheer Desire ET 1060 Handpiece	LightSheer Desire ET 1060 Handpiece	FDA UDI	Class II	Unknown
VersaPulse PowerSuite	VersaPulse PowerSuite 100W	FDA UDI	Class II	Active
Digital AcuBlade™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for 008-xxxx and above, 110V	FDA UDI	Class II	Active
Aspiration Disposables Kit	Aspiration Disposables Kit	FDA UDI	Class II	Active
VersaPulse PowerSuite 80W	VersaPulse PowerSuite 80W	FDA UDI	Class II	Active
Lumenis Pulse 100H	Lumenis Pulse 100H	FDA UDI	Class II	Active
Stellart M22 - ResurFX Upgrade	Stellart M22 - ResurFX Upgrade	FDA UDI	Class II	Unknown
AcuPulse™ Upgrade Kit 40 to 40AES-R	AcuPulse™ Upgrade Kit 40 to 40AES-R	FDA UDI	Class II	Unknown
Lumenis Pulse 60H, 60Hz	Lumenis Pulse 60H, 60Hz	FDA UDI	Class II	Active
VersaPulse PowerSuite	VersaPulse PowerSuite 80/100W	FDA UDI	Class II	Active
SurgiTouch Scanning Handpiece 260mm	SurgiTouch Scanning Handpiece 260mm	FDA UDI	Class II	Unknown
Nasal Probe Straight Tip, 90 Degree Left Mirror Smoke Evacuation Channel	14636	FDA UDI	Class II	Active
M22 ResurFX Handpiece	M22 ResurFX Handpiece	FDA UDI	Class II	Unknown
Slimline EZ 550 Fiber	Slimline EZ 550 Fiber	FDA UDI	Class II	Active
UltraPulse Focused Incisional HandPiece set	UltraPulse Focused Incisional HandPiece set	FDA UDI	Class II	Unknown
VersaPulse PowerSuite 100W	VersaPulse PowerSuite 100W	FDA UDI	Class II	Active
VersaPulse PowerSuite 100W	VersaPulse PowerSuite 100W	FDA UDI	Class II	Active
SurgiTouch™ Scanner	SurgiTouch™ Scanner	FDA UDI	Class II	Unknown
Universal IPL 515 nm Expert Filter	Universal IPL 515 nm Expert Filter (Set 4)	FDA UDI	Class II	Unknown
Lumenis Pulse 120H	Lumenis Pulse 120H	FDA UDI	Class II	Active
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for up to 007-xxxx, 100V CPG	FDA UDI	Class II	Active
Acculite EndoOto	24ga 10° Angled, SMA 905, 200µm	FDA UDI	Class II	Unknown
FemTouch™	FemTouch™	FDA UDI	Class II	Unknown
FiberLase™ HP-M 140 mm malleable	FiberLase™ HP-M 140 mm malleable	FDA UDI	Class II	Active
AcuPulse™ DUO HW Upgrade kit AcuPulse™ 40WG to DUO	AcuPulse™ DUO HW Upgrade kit AcuPulse™ 40WG to DUO	FDA UDI	Class II	Active
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™	Kit for 008-xxxx and above, 220V	FDA UDI	Class II	Unknown
OPT Module Kit	OPT Module Kit	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