FDA 510(k)

Diode Laser Therapy Machine

K-Number: K161692 · 2016-11-16

ApplicantBeijing Adss Development Co., Ltd.

Decision Date2016-11-16

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy Machine is a medical device manufactured by Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2016-11-16 under approval number K161692. 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 Therapy Machine?

Diode Laser Therapy Machine is a medical device that received FDA 510(k) clearance on 2016-11-16. It is manufactured by Beijing Adss Development Co., Ltd.. The 510(k) number is K161692.

When was Diode Laser Therapy Machine approved by the FDA?

Diode Laser Therapy Machine received FDA 510(k) clearance on 2016-11-16, under approval number K161692.

What company makes Diode Laser Therapy Machine?

Diode Laser Therapy Machine is manufactured by Beijing Adss Development Co., Ltd..

What is the FDA product code for Diode Laser Therapy Machine?

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

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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.