FDA 510(k)

CO2 Laser System

K-Number: K191518 · 2019-09-12

Decision Date2019-09-12

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CO2 Laser System is a medical device manufactured by Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2019-09-12 under approval number K191518. 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 CO2 Laser System?

CO2 Laser System is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K191518.

When was CO2 Laser System approved by the FDA?

CO2 Laser System received FDA 510(k) clearance on 2019-09-12, under approval number K191518.

What company makes CO2 Laser System?

CO2 Laser System is manufactured by Shenzhen Gsd Tech Co., Ltd..

What is the FDA product code for CO2 Laser System?

The FDA product code for CO2 Laser System is GEX. This falls under the Gastroenterology category.

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Other Devices by Shenzhen Gsd Tech Co., Ltd.

K180383Light based hair removal device K202827308nm Excimer UV-light Skin Therapy System K213225Diode Laser System GP900A8, Diode Laser System GP900Q8 K230060Light Based Hair Removal Device GP592

Related Devices (Code: GEX)

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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.