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FDA 510(k)

Q Switched Nd: YAG Laser machine

K-Number: K193609 · 2020-03-20

Decision Date2020-03-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q Switched Nd: YAG Laser machine is a medical device manufactured by Beijing Lead Beauty S & T Co., Ltd.. It received FDA 510(k) clearance on 2020-03-20 under approval number K193609. 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 Q Switched Nd: YAG Laser machine?

Q Switched Nd: YAG Laser machine is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Beijing Lead Beauty S & T Co., Ltd.. The 510(k) number is K193609.

When was Q Switched Nd: YAG Laser machine approved by the FDA?

Q Switched Nd: YAG Laser machine received FDA 510(k) clearance on 2020-03-20, under approval number K193609.

What company makes Q Switched Nd: YAG Laser machine?

Q Switched Nd: YAG Laser machine is manufactured by Beijing Lead Beauty S & T Co., Ltd..

What is the FDA product code for Q Switched Nd: YAG Laser machine?

The FDA product code for Q Switched Nd: YAG Laser machine is GEX. This falls under the Gastroenterology category.

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Official Source

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