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FDA 510(k)

Diode Laser Treatment System

K-Number: K182924 · 2019-04-15

ApplicantWeifang KM Electronics Co., Ltd.
Decision Date2019-04-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Treatment System is a medical device manufactured by Weifang KM Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-04-15 under approval number K182924. 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 Diode Laser Treatment System?

Diode Laser Treatment System is a medical device that received FDA 510(k) clearance on 2019-04-15. It is manufactured by Weifang KM Electronics Co., Ltd.. The 510(k) number is K182924.

When was Diode Laser Treatment System approved by the FDA?

Diode Laser Treatment System received FDA 510(k) clearance on 2019-04-15, under approval number K182924.

What company makes Diode Laser Treatment System?

Diode Laser Treatment System is manufactured by Weifang KM Electronics Co., Ltd..

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

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

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Related PubMed Literature

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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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