FoLix
K-Number: K242349 · 2024-09-09
ApplicantLumenis Be, Ltd.
Decision Date2024-09-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FoLix is a medical device manufactured by Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2024-09-09 under approval number K242349. 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 FoLix?
FoLix is a medical device that received FDA 510(k) clearance on 2024-09-09. It is manufactured by Lumenis Be, Ltd.. The 510(k) number is K242349.
When was FoLix approved by the FDA?
FoLix received FDA 510(k) clearance on 2024-09-09, under approval number K242349.
What company makes FoLix?
FoLix is manufactured by Lumenis Be, Ltd..
What is the FDA product code for FoLix?
The FDA product code for FoLix 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.