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Lumenis Be, Inc.

United States·US-MF-000016037

Last updated May 24, 2026

Part of Lumenis Be Ltd

Information

Country: United States
Address: 1870 S. Milestone Dr, Salt Lake city, UT, United States
Website: lumenis.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Karen Smith
EUDAMED SRN: US-MF-000016037
FDA FEI Number: —
DUNS Number: 118292380

Catalogue (63)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Radd	RADD	FDA UDI	Class II	Unknown
OPT™ Shields	NA	FDA UDI	Class I	Active
LightSheer Desire	NA	FDA UDI	Class II	Active
LightSheer® Duet HS™ Handpiece	NA	FDA UDI	Class II	Active
AcuPulse Incisional Handpiece 125 mm	NA	FDA UDI	Class II	Active
Endo kit with Automatic Eye Safety Filter	Endo kit with Auto 532/577/659 nm	FDA UDI	Class II	Active
Vision One	Green	FDA UDI	Class II	Active
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems	K220877	FDA 510(k)	Class II	Active
GA-1005557Be	GA-1005557Be	EUDAMEDFDA UDI	Class IIb	Active
GAS900000LEDBe	GAS900000LEDBe	EUDAMEDFDA UDI	Class IIb	Active
0642-936-01Be	0642-936-01Be	EUDAMEDFDA UDI	Class IIb	Active
GAS900000DIGBe	GAS900000DIGBe	EUDAMEDFDA UDI	Class IIb	Active
Ga-0001300	GA-0001300	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

Lumenis (Germany) GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

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