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Periolase Nd:YAG Dental Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K030290

by Millennium Dental Technologies, Inc.

Identifiers

510(k) Number
K030290 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 Periolase Nd:YAG Dental Laser System is a dental laser device designed for use in dental procedures. It is a free-running variable pulsed Nd:YAG laser system intended for intraoral soft tissue applications.

The device is supplied as a reusable system and is used in dental settings for procedures involving soft tissue. It has been authorized via FDA 510(k) clearance under product code GEX, with clearance granted on July 26, 2004, under K030290.

Frequently asked questions

What is the Periolase Nd:YAG Dental Laser System used for?

The Periolase Nd:YAG Dental Laser System is intended for intraoral soft tissue applications in dental procedures, as it is a free-running variable pulsed Nd:YAG laser designed specifically for use on soft tissue within the mouth.

Is the Periolase Nd:YAG Dental Laser System reusable or single-use?

The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures, consistent with its intended use in dental settings.

How was the Periolase Nd:YAG Dental Laser System authorized for market release?

The device received authorization via FDA 510(k) clearance under product code GEX, with the determination of substantial equivalence granted on July 26, 2004, under submission number K030290.

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: About PerioLase® - Millennium Dental Technologies, Inc., Dental surgery laser - PerioLase MVP-7 - Millennium Dental Technologies ..., Clinicians - Millennium Dental Technologies, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Millennium Dental Technologies, Inc.

Sources (1)

  • FDA 510(k) K030290 24 fields · synced Sep 22, 2026