Lavieen
K-Number: K223727 · 2023-08-25
ApplicantWontech Co., Ltd.
Decision Date2023-08-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Lavieen is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-25 under approval number K223727. 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 Lavieen?
Lavieen is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K223727.
When was Lavieen approved by the FDA?
Lavieen received FDA 510(k) clearance on 2023-08-25, under approval number K223727.
What company makes Lavieen?
Lavieen is manufactured by Wontech Co., Ltd..
What is the FDA product code for Lavieen?
The FDA product code for Lavieen 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.