Waterlase MD
by Biolase Technology, Inc. 2 variants
510(k) K090181
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090181 | Date11 Feb 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Waterlase MD is a dental laser system that combines a YSGG laser with a water spray for tissue ablation. It is designed for minimally invasive procedures in dental applications.
It is supplied as a reusable device for use in dental clinical settings. The device has received FDA 510(k) clearance under product code GEX and is authorized for marketing in the United States.
Other devices from Biolase Technology, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Waterlase MD used for?
The Waterlase MD is used for minimally invasive procedures in dental applications, such as tissue ablation.
Is the Waterlase MD reusable?
Yes, the Waterlase MD is supplied as a reusable device for use in dental clinical settings.
What kind of laser does the Waterlase MD use?
The Waterlase MD uses a YSGG laser combined with a water spray for tissue ablation.