LaserME
K-Number: K230077 · 2023-07-17
ApplicantNeauvia North America
Decision Date2023-07-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LaserME is a medical device manufactured by Neauvia North America. It received FDA 510(k) clearance on 2023-07-17 under approval number K230077. 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 LaserME?
LaserME is a medical device that received FDA 510(k) clearance on 2023-07-17. It is manufactured by Neauvia North America. The 510(k) number is K230077.
When was LaserME approved by the FDA?
LaserME received FDA 510(k) clearance on 2023-07-17, under approval number K230077.
What company makes LaserME?
LaserME is manufactured by Neauvia North America.
What is the FDA product code for LaserME?
The FDA product code for LaserME 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.