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Sign in to claim this brandBiolase, Inc.
US
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
- —
- —
- [email protected]
- Phone
- 1-800-321-6717
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 152165700
Catalogue (190)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Waterlase Laser Tips | Z4-22 | FDA UDI | Class II | Active |
| Diode Laser Tips | E4-60 EZTip | FDA UDI | Class II | Active |
| Diode Laser Tips | Pre-initiated, Perio, 4-7 | FDA UDI | Class II | Active |
| Waterlase iPlus Dental Laser System | 7200854-013 Refurbished | FDA UDI | Class II | Active |
| Waterlase Laser Tips | C6-6, single | FDA UDI | Class II | Active |
| Diode Laser Tips | E4-7 EZ Tips | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MZ3-18 | FDA UDI | Class II | Active |
| Waterlase MDX 450 Laser System | 7200860-06 Refurbished | FDA UDI | Class II | Active |
| Whitening Handpiece Disposable Shields | 6400180 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MG6-4 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MC6-9 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MZ3-28 | FDA UDI | Class II | Active |
| Waterlase iPlus Dental Laser System | 7200854-14 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | Z4-20 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | Z6-14 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MZ3-25 | FDA UDI | Class II | Active |
| Diode Laser Tips | perio, E4-9, single tip | FDA UDI | Class II | Active |
| Waterlase Laser Tips | RFT3-21 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MZ6-4 | FDA UDI | Class II | Active |
| EdgePro | Tip Assembly - One-21 mm, WL JUNO | FDA UDI | Class II | Active |
| Diode Laser Tips | Pre-initiated, Surgical, 3-4 | FDA UDI | Class II | Active |
| Waterlase Laser System Gold Handpiece | 6200500 Refurbished | FDA UDI | Class II | Unknown |
| Waterlase Laser Tips | Z2-33 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MX11 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | S75-6 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MZ3-14 | FDA UDI | Class II | Active |
| Waterlase Laser Tips | MC3-9 | FDA UDI | Class II | Active |
| Waterlase iPlus Dental Laser System | 7200854-012 Refurbished | FDA UDI | Class II | Active |
| Epic T-Series Diode Laser System | 7400055 Refurbished | FDA UDI | Class II | Active |
| Epic S-Series Diode Laser System | 7400054 | FDA UDI | Class II | Active |
| Waterlase iPlus Dental Laser System | 7200854-02 Refurbished | FDA UDI | Class II | Active |
| Diode Laser System Whitening Handpiece | 7400022 Refurbished | FDA UDI | Class II | Unknown |
| Waterlase Express Handpiece | Handpiece, 1PK, refurbished | FDA UDI | Class II | Active |
| laserwhite20 Whitening Gel | laserwhite20 | FDA UDI | Class II | Active |
| Epic Pro 940 | K172771 | FDA 510(k) | Class II | Active |
| Epic 980 | K193486 | FDA 510(k) | Class II | Active |
| Epic 980 | K192430 | FDA 510(k) | Class II | Active |
| EdgePro | K213428 | FDA 510(k) | Class II | Active |
| Waterlase Laser System Family | K190319 | FDA 510(k) | Class II | Active |
| Waterlase Iplus S | K141975 | FDA 510(k) | Class II | Active |
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