CO2 Laser System
K-Number: K260257 · 2026-03-28
ApplicantSanhe Meditech Co., Ltd.
Decision Date2026-03-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CO2 Laser System is a medical device manufactured by Sanhe Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-03-28 under approval number K260257. 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 2026-03-28. It is manufactured by Sanhe Meditech Co., Ltd.. The 510(k) number is K260257.
When was CO2 Laser System approved by the FDA?
CO2 Laser System received FDA 510(k) clearance on 2026-03-28, under approval number K260257.
What company makes CO2 Laser System?
CO2 Laser System is manufactured by Sanhe Meditech 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.