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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 the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Gigaa Optronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-07 under 510(k) 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. The listed applicant is Wuhan Gigaa Optronics Technology Co., Ltd.. The 510(k) number is K160549.

When did MEDICAL DIODE LASER SYSTEMS receive FDA 510(k) clearance?

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

Who is the listed applicant for MEDICAL DIODE LASER SYSTEMS?

The FDA 510(k) record lists Wuhan Gigaa Optronics Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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