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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Waterlase Laser Tips - Quartz	7200722	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7200112	EUDAMEDFDA UDI	Class IIa	Active
Waterlase iPlus Laser System	7200854-205	EUDAMEDFDA UDI	Class IIb	Active
Waterlase MDX 300 Laser System	7200861-06	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7000186	EUDAMED	Class IIa	Active
Waterlase Express Laser System	7210001	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7000308	EUDAMED	Class IIa	Active
Waterlase iPlus Laser System	7200854-212	EUDAMEDFDA UDI	Class IIb	Active
Diode Laser Tips - Non Initiated Tips	7400017	EUDAMED	Class IIa	Active
Diode Laser Tips - Non Initiated Tips	7400020	EUDAMEDFDA UDI	Class IIa	Active
Waterlase iPlus Laser System	7200854-16	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-211	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-13	EUDAMEDFDA UDI	Class IIb	Active
Diode Laser Tips - Non Initiated Tips	7400056	EUDAMED	Class IIa	Active
Diode Laser Tips - Non Initiated Tips	7400053	EUDAMEDFDA UDI	Class IIa	Active
Waterlase iPlus Laser System	7200854-15	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7200170	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200732	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Quartz	7000680	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200823	EUDAMED	Class IIa	Active
iLase Laser System	7400040-01	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Sapphire	7200800	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Sapphire	7000303	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7230002	EUDAMED	Class IIa	Active
Laser Handpiece	7400022	EUDAMED	Class I	Active
Waterlase Laser Tips - Quartz	7200712	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7000684	EUDAMEDFDA UDI	Class IIa	Active
Waterlase iPlus Laser System	7200854-214	EUDAMEDFDA UDI	Class IIb	Active
Epic Q Diode Laser System	7410008	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7200828	EUDAMEDFDA UDI	Class IIa	Active
Diode Laser Tips - Non Initiated Tips	7400072	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7200891	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips - Quartz	7000176	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7000166	EUDAMED	Class IIa	Active
Waterlase Laser Tips	7200107	EUDAMEDFDA UDI	Class IIa	Active
Laser Handpiece	7220003	EUDAMEDFDA UDI	Class I	Active
Waterlase iPlus Laser System	7200854-17	EUDAMEDFDA UDI	Class IIb	Active
Laser Handpiece	7220002	EUDAMEDFDA UDI	Class I	Active
Waterlase Laser Tips - Quartz	7200174	EUDAMED	Class IIa	Active
Waterlase iPlus Laser System	7200854-217	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-05	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-203	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7200795	EUDAMEDFDA UDI	Class IIa	Active
Waterlase Laser Tips	7200824	EUDAMEDFDA UDI	Class IIa	Active
Epic 10 Diode Laser System	7400042	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-02	EUDAMEDFDA UDI	Class IIb	Active
Waterlase iPlus Laser System	7200854-11	EUDAMEDFDA UDI	Class IIb	Active
Waterlase Laser Tips - Quartz	7200711	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Sapphire	7200867	EUDAMED	Class IIa	Active
Waterlase Laser Tips - Quartz	7200403	EUDAMEDFDA UDI	Class IIa	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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