CO2 Laser System
K-Number: K221597 · 2022-09-15
Decision Date2022-09-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CO2 Laser System is a medical device manufactured by Smedtrum Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-15 under approval number K221597. 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 2022-09-15. It is manufactured by Smedtrum Medical Technology Co., Ltd.. The 510(k) number is K221597.
When was CO2 Laser System approved by the FDA?
CO2 Laser System received FDA 510(k) clearance on 2022-09-15, under approval number K221597.
What company makes CO2 Laser System?
CO2 Laser System is manufactured by Smedtrum Medical Technology 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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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.