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BIOLASE MG LLC

United States·US-MF-000028587

Last updated September 17, 2026

Information

Country: United States
Address: 27042, Towne Centre Drive, Foothill Ranch, United States
Website: www.biolase.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Youhyun Yoon
EUDAMED SRN: US-MF-000028587
FDA FEI Number: 2027755
DUNS Number: —

Catalogue (134)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Waterlase iPlus Laser System	7200854-14	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7000307	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7200684	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Sapphire	7200690	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7000615	EUDAMEDFDA UDI	Class IIa	Active
Waterlase iPlus Laser System	7200854-04	EUDAMEDFDA UDI	Class IIb	Active
Laser Handpiece	6400105	EUDAMEDFDA UDI	Class I	Active
Waterlase Laser Tips - Quartz	7000174	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7000613	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200113	EUDAMED	Class IIa	Active
Epic X Diode Laser System	7400073	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Sapphire	7000612	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7200831	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Sapphire	7000800	EUDAMEDFDA UDI	Class IIa	Active
Diode Laser Tips - Pre Initiated Tips	6400564	EUDAMEDFDA UDI	Class IIa	Active
Epic V Diode Laser System	7400048	EUDAMED	Class IIb	Active
Waterlase Laser Tips	7000825	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Quartz	7200801	EUDAMEDFDA UDI	Class IIa	Active
Waterlase iPlus Laser System	7200854-209	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-202	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7000164	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200307	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7230001	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Quartz	7200175	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200713	EUDAMED	Class IIa	Active
Diode Laser Tips - Non Initiated Tips	7410002	EUDAMED	Class IIa	Active
Epic Hygiene Diode Laser System	7410006	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-01	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7000184	EUDAMED	Class IIa	Active
Waterlase iPlus Laser System	7200854-201	EUDAMEDFDA UDI	Class IIb	Active
Laser Handpiece	6400479	EUDAMEDFDA UDI	Class I	Active
Waterlase Laser Tips - Quartz	7000170	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200863	EUDAMED	Class IIa	Active
Diode Laser Tips - Pre Initiated Tips	7400067	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7000185	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200731	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Sapphire	7200406	EUDAMEDFDA UDI	Class IIa	Active
Waterlase iPlus Laser System	7200854-12	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Sapphire	7230003	EUDAMED	Class IIa	Active
Waterlase Laser Tips	7230005	EUDAMED	Class IIa	Active
Waterlase iPlus Laser System	7200854-03	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7000162	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200851	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200733	EUDAMEDFDA UDI	Class IIa	Active
Waterlase MDX 450 Laser System	7200860-06	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7200730	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Quartz	7200723	EUDAMED	Class IIa	Active
Diode Laser Tips - Pre Initiated Tips	7430001	EUDAMED	Class IIa	Active
Waterlase iPlus Laser System	7200854-09	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-207	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

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Notified Bodies

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Authorities

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