Biolase, Inc.
United StatesFDA applicant, unverified
Biolase, Inc. is a medical device manufacturer, with 191 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 191
Registry facts
- Registries
- FDA GUDID 184
- FDA 510(k) 7
- Device classes
- FDA Class II 191
- Identifiers
- DUNS 152165700
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.
The devices are listed within the FDA 510(k) premarket notification database and the FDA Unique Device Identification (UDI) system.
Catalogue
Search and filter all 191 devicesShowing 1-50 of 191
Company details
- DUNS number
- 152165700
- Phone
- 1-800-321-6717
Frequently asked questions
How many devices does Biolase, Inc. have in the registry?
The registry currently lists 191 devices for Biolase, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biolase, Inc.'s devices?
Among its 50 most recently registered devices, Biolase, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biolase, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Biolase, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biolase, Inc. in the registry?
The most recently registered devices listed for Biolase, Inc. include EPIC 10, Waterlase Laser Tips MX7, Waterlase iPlus Dental Laser System and Waterlase iPlus Dental Laser System 7200854-04 Refurbished.