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FDA 510(k)

FoLix

K-Number: K242349 · 2024-09-09

ApplicantLumenis Be, Ltd.
Decision Date2024-09-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FoLix is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2024-09-09 under 510(k) 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. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K242349.

When did FoLix receive FDA 510(k) clearance?

FoLix received FDA 510(k) clearance on 2024-09-09, under 510(k) number K242349.

Who is the listed applicant for FoLix?

The FDA 510(k) record lists Lumenis Be, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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