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Biolase, Inc.

Last updated May 24, 2026

What Biolase, Inc. makes

Biolase, Inc. manufactures dental solid-state and diode laser systems, including the Waterlase iPlus Dental Laser System. The company also produces general surgical laser systems, musculoskeletal therapy lasers, and associated accessories such as reusable and single-use beam guides, deep tissue handpieces, and single-use equipment drapes. Additionally, the product portfolio includes tooth-desensitizing dental coatings and various laser tips.

These products are classified as Class II medical devices and are based in the United States. The devices are listed within the FDA 510(k) premarket notification database and the FDA Unique Device Identification (UDI) system.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Biolase, Inc. manufacture?

Biolase, Inc. manufactures a diverse range of medical equipment primarily focused on laser technology. Their product portfolio includes dental solid-state and diode laser systems, such as the Waterlase iPlus Dental Laser System, as well as general surgical laser systems and musculoskeletal therapy lasers. They also produce various accessories, including reusable and single-use beam guides, deep tissue handpieces, laser tips, single-use equipment drapes, and tooth-desensitizing dental coatings.

Where is Biolase, Inc. based?

Biolase, Inc. is based in the United States. This information is provided to clarify the geographic origin of the manufacturer as stated in the company's regulatory documentation.

How are the devices produced by Biolase, Inc. classified?

The medical devices manufactured by Biolase, Inc. are classified as Class II devices. This classification is based on the regulatory data provided for their product line, which includes various laser systems and associated surgical or dental accessories.

Which regulatory registries list the devices from Biolase, Inc.?

The devices manufactured by Biolase, Inc. are listed in the FDA 510(k) premarket notification database and the FDA Unique Device Identification (UDI) system. These registries are used to track medical device information and regulatory status in the United States.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: biolase.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-321-6717
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 152165700

Catalogue (190)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Diode Laser Tips	E3-7 EZ Tips	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-09	FDA UDI	Class II	Active
Epic Hygiene Diode Laser System	Laser System, Replacement	FDA UDI	Class II	Active
Waterlase Laser Tips	RFT3-17	FDA UDI	Class II	Active
Waterlase Laser Tips	MC12-9	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-05 Refurbished	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	Fractional Handpiece Kit	FDA UDI	Class II	Active
Epic X Diode Laser System	7400073 Refurbished	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-014 Refurbished	FDA UDI	Class II	Active
Diode Laser Tips	E2-4 EZ Tips	FDA UDI	Class II	Active
Waterlase Express Handpiece	Handpiece, Single Unpacked	FDA UDI	Class II	Active
Diode Laser Tips	E4-100 EZ Tips	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-12	FDA UDI	Class II	Active
Diode Laser Tips	Pre-initiated, Perio, 3-7	FDA UDI	Class II	Active
Diode Laser Tips	EpiTip 3-7 Perio	FDA UDI	Class II	Unknown
Waterlase Laser System Turbo Handpiece	6201126	FDA UDI	Class II	Active
Waterlase Laser Tips	MZ10-6 Zip Tips	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-03 Refurbished	FDA UDI	Class II	Active
Diode Laser Tips	Pre-Initiated, Perio, 4-9	FDA UDI	Class II	Active
Diode Laser Tips	E4-4 EZ Tips	FDA UDI	Class II	Active
Waterlase Laser Tips	Z6-6	FDA UDI	Class II	Active
Diode Laser Tips	EpiTip 4-4 Surgical	FDA UDI	Class II	Unknown
Waterlase Laser Tips	Z6-9	FDA UDI	Class II	Active
Waterlase Laser Tips	Z3-25	FDA UDI	Class II	Active
Diode Laser Tips	PI Pro Tips, Surgical, 4-4	FDA UDI	Class II	Active
Diode Laser Tips	Pre-Initiated, Perio, 3-9	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-01 Refurbished	FDA UDI	Class II	Active
Epic Pro Diode Laser System	Dental soft tissue diode laser system refurbished	FDA UDI	Class II	Active
Diode Laser Tips	E2-20 EZ Tips	FDA UDI	Class II	Active
Waterlase Laser Tips	MG6-9	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-07 Refurbished	FDA UDI	Class II	Active
EdgePro	Tip Assembly - Two-17mm, WL JUNO	FDA UDI	Class II	Active
Waterlase Laser Tips	Z2-22	FDA UDI	Class II	Active
Waterlase Laser Tips	Tip, MZ6-17mm	FDA UDI	Class II	Active
Waterlase Laser Tips	Z2-20	FDA UDI	Class II	Active
Deep Tissue Handpiece Disposable Shields	6400310	FDA UDI	Class II	Active
Waterlase iPlus Dental Laser System	7200854-02	FDA UDI	Class II	Active
Waterlase Laser Tips	MX9	FDA UDI	Class II	Active
Waterlase Laser Tips	Z4-18	FDA UDI	Class II	Active
Diode Laser Tips	EpiTip 4-9 Perio	FDA UDI	Class II	Unknown
Waterlase iPlus Dental Laser System	7200854-07	FDA UDI	Class II	Active
Diode Laser System Whitening Handpiece	7400022	FDA UDI	Class II	Active
Waterlase Laser System Turbo Handpiece	6201126 Refurbished	FDA UDI	Class II	Unknown
EdgePro	Tip Assembly - Three-10mm, WL JUNO	FDA UDI	Class II	Active
Epic T-Series Diode Laser System	7400055	FDA UDI	Class II	Active
Waterlase Laser Tips	MZ3-22	FDA UDI	Class II	Active
Waterlase Laser Tips	Z3-22	FDA UDI	Class II	Active
Waterlase Laser Tips	RFPT8-14	FDA UDI	Class II	Active
Diode Laser Tips	perio, E3-9, single tip	FDA UDI	Class II	Active
Waterlase Laser Tips	C3-9	FDA UDI	Class II	Active

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