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FDA 510(k)

PerioLase Nd:YAG Pulsed Dental Laser System

K-Number: K182930 · 2019-07-12

ApplicantMillennium Dental Technologies, Inc.
Decision Date2019-07-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PerioLase Nd:YAG Pulsed Dental Laser System is a medical device manufactured by Millennium Dental Technologies, Inc.. It received FDA 510(k) clearance on 2019-07-12 under approval number K182930. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PerioLase Nd:YAG Pulsed Dental Laser System?

PerioLase Nd:YAG Pulsed Dental Laser System is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Millennium Dental Technologies, Inc.. The 510(k) number is K182930.

When was PerioLase Nd:YAG Pulsed Dental Laser System approved by the FDA?

PerioLase Nd:YAG Pulsed Dental Laser System received FDA 510(k) clearance on 2019-07-12, under approval number K182930.

What company makes PerioLase Nd:YAG Pulsed Dental Laser System?

PerioLase Nd:YAG Pulsed Dental Laser System is manufactured by Millennium Dental Technologies, Inc..

What is the FDA product code for PerioLase Nd:YAG Pulsed Dental Laser System?

The FDA product code for PerioLase Nd:YAG Pulsed Dental Laser System is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other Devices by Millennium Dental Technologies, Inc.

K151763PerioLase Nd:YAG Pulsed Dental Laser System

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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