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Waterlase Laser System Family

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190319

by Biolase, Inc.

Identifiers

510(k) Number
K190319 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Waterlase Laser System Family is a dental laser device designed for use in dental procedures. It is classified as a substantially equivalent device under FDA 510(k) clearance.

The device is supplied as a reusable system and is intended for use by dental professionals. It is not specified as single-use or sterile in the provided data.

Frequently asked questions

What is the Waterlase Laser System Family used for?

The Waterlase Laser System Family is a dental laser device designed for use by dental professionals in dental procedures.

Is the Waterlase Laser System Family a single-use device?

No, the device is supplied as a reusable system and is not specified as single-use in the provided data.

What is the regulatory status of the Waterlase Laser System Family?

The device is classified as a substantially equivalent device under FDA 510(k) clearance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: All-Tissue Dental Lasers - Waterlase | BIOLASE, BIOLASE Dental Lasers | Global Leadership in Dentistry, Biolase® Waterlase — Premier Dental Care

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biolase, Inc.

Sources (1)

  • FDA 510(k) K190319 24 fields · synced Oct 1, 2026