Lavieen
K-Number: K241406 · 2024-06-28
ApplicantWontech Co., Ltd.
Decision Date2024-06-28
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 2024-06-28 under approval number K241406. 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 2024-06-28. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K241406.
When was Lavieen approved by the FDA?
Lavieen received FDA 510(k) clearance on 2024-06-28, under approval number K241406.
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.
Other Devices by Wontech Co., Ltd.
Related Devices (Code: GEX)
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.
K163222Discovery Pico FamilyQuanta System Spa
K163009LithoQuanta System Spa
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.
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.