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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 the device name listed in this FDA 510(k) record. The listed applicant is Millennium Dental Technologies, Inc.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) 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. The listed applicant is Millennium Dental Technologies, Inc.. The 510(k) number is K182930.

When did PerioLase Nd:YAG Pulsed Dental Laser System receive FDA 510(k) clearance?

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

Who is the listed applicant for PerioLase Nd:YAG Pulsed Dental Laser System?

The FDA 510(k) record lists Millennium Dental Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04429607Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled TrialENROLLING_BY_INVITATIONNCT06721975Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)RECRUITINGNCT07516106Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With FANS Access SheathsNOT_YET_RECRUITINGNCT07599709LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARSCOMPLETEDNCT07651774Effect of Low-Level Laser Therapy on Spontaneous and Chewing Pain Associated With Orthodontic Elastomeric Separator PlacementCOMPLETEDNCT07739420A Randomized, Assessor-Blinded, Intraindividual Study on the Efficacy of Fractional Carbon Dioxide Laser Versus Long-Pulsed 1064 nm Nd:YAG Laser in the Treatment of Keratosis PilarisCOMPLETED

Other records listing Millennium Dental Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K151763PerioLase Nd:YAG Pulsed Dental Laser System

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

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