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FDA 510(k)

MEDICAL DIODE LASER SYSTEMS

K-Number: K160549 · 2017-04-07

ApplicantWuhan Gigaa Optronics Technology Co., Ltd.
Decision Date2017-04-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDICAL DIODE LASER SYSTEMS is a medical device manufactured by Wuhan Gigaa Optronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-07 under approval number K160549. 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 MEDICAL DIODE LASER SYSTEMS?

MEDICAL DIODE LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2017-04-07. It is manufactured by Wuhan Gigaa Optronics Technology Co., Ltd.. The 510(k) number is K160549.

When was MEDICAL DIODE LASER SYSTEMS approved by the FDA?

MEDICAL DIODE LASER SYSTEMS received FDA 510(k) clearance on 2017-04-07, under approval number K160549.

What company makes MEDICAL DIODE LASER SYSTEMS?

MEDICAL DIODE LASER SYSTEMS is manufactured by Wuhan Gigaa Optronics Technology Co., Ltd..

What is the FDA product code for MEDICAL DIODE LASER SYSTEMS?

The FDA product code for MEDICAL DIODE LASER SYSTEMS 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.

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