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FDA 510(k)

980nm Diode Laser Therapy Device

K-Number: K191349 · 2019-08-16

ApplicantShanghai Apolo Medical Technology Co., Ltd.
Decision Date2019-08-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

980nm Diode Laser Therapy Device is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-08-16 under approval number K191349. 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 980nm Diode Laser Therapy Device?

980nm Diode Laser Therapy Device is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K191349.

When was 980nm Diode Laser Therapy Device approved by the FDA?

980nm Diode Laser Therapy Device received FDA 510(k) clearance on 2019-08-16, under approval number K191349.

What company makes 980nm Diode Laser Therapy Device?

980nm Diode Laser Therapy Device is manufactured by Shanghai Apolo Medical Technology Co., Ltd..

What is the FDA product code for 980nm Diode Laser Therapy Device?

The FDA product code for 980nm Diode Laser Therapy Device is GEX. This falls under the Gastroenterology category.

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Other Devices by Shanghai Apolo Medical Technology Co., Ltd.

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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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