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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 the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2016-11-16 under 510(k) 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. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K161692.

When did Diode Laser Therapy Machine receive FDA 510(k) clearance?

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

Who is the listed applicant for Diode Laser Therapy Machine?

The FDA 510(k) record lists Beijing Adss Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Beijing Adss Development Co., Ltd. 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.

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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

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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