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FDA 510(k)

Dental Diode Laser System

K-Number: K180967 · 2018-07-11

ApplicantLazon Medical Laser Co., Ltd.
Decision Date2018-07-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dental Diode Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lazon Medical Laser Co., Ltd.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K180967. 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 Dental Diode Laser System?

Dental Diode Laser System is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Lazon Medical Laser Co., Ltd.. The 510(k) number is K180967.

When did Dental Diode Laser System receive FDA 510(k) clearance?

Dental Diode Laser System received FDA 510(k) clearance on 2018-07-11, under 510(k) number K180967.

Who is the listed applicant for Dental Diode Laser System?

The FDA 510(k) record lists Lazon Medical Laser Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Diode Laser System?

The FDA product code for Dental Diode 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.

NCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07651774Effect of Low-Level Laser Therapy on Spontaneous and Chewing Pain Associated With Orthodontic Elastomeric Separator PlacementCOMPLETEDNCT07707063This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis PatientsRECRUITING

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.

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Official Source

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

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