CO2 Laser Machine (Lume)
K-Number: K250465 · 2025-06-09
ApplicantNanjing Bestview Laser S&T Co., Ltd.
Decision Date2025-06-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CO2 Laser Machine (Lume) is a medical device manufactured by Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2025-06-09 under approval number K250465. 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 Machine (Lume)?
CO2 Laser Machine (Lume) is a medical device that received FDA 510(k) clearance on 2025-06-09. It is manufactured by Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K250465.
When was CO2 Laser Machine (Lume) approved by the FDA?
CO2 Laser Machine (Lume) received FDA 510(k) clearance on 2025-06-09, under approval number K250465.
What company makes CO2 Laser Machine (Lume)?
CO2 Laser Machine (Lume) is manufactured by Nanjing Bestview Laser S&T Co., Ltd..
What is the FDA product code for CO2 Laser Machine (Lume)?
The FDA product code for CO2 Laser Machine (Lume) 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.