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FDA 510(k)

LightMed Dental Laser System

K-Number: K170073 · 2017-07-25

ApplicantLightmed Dentaltechnology Corp.
Decision Date2017-07-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LightMed Dental Laser System is a medical device manufactured by Lightmed Dentaltechnology Corp.. It received FDA 510(k) clearance on 2017-07-25 under approval number K170073. 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 LightMed Dental Laser System?

LightMed Dental Laser System is a medical device that received FDA 510(k) clearance on 2017-07-25. It is manufactured by Lightmed Dentaltechnology Corp.. The 510(k) number is K170073.

When was LightMed Dental Laser System approved by the FDA?

LightMed Dental Laser System received FDA 510(k) clearance on 2017-07-25, under approval number K170073.

What company makes LightMed Dental Laser System?

LightMed Dental Laser System is manufactured by Lightmed Dentaltechnology Corp..

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

The FDA product code for LightMed Dental Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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