Alma Veil
K-Number: K251094 · 2025-05-06
ApplicantWontech Co., Ltd.
Decision Date2025-05-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Alma Veil is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2025-05-06 under approval number K251094. 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 Alma Veil?
Alma Veil is a medical device that received FDA 510(k) clearance on 2025-05-06. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K251094.
When was Alma Veil approved by the FDA?
Alma Veil received FDA 510(k) clearance on 2025-05-06, under approval number K251094.
What company makes Alma Veil?
Alma Veil is manufactured by Wontech Co., Ltd..
What is the FDA product code for Alma Veil?
The FDA product code for Alma Veil 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.