Alma Veil
K号: K251094 · 2025-05-06
广告
器械摘要
Alma Veil is the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2025-05-06 under 510(k) 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.
常见问题
What is the Alma Veil?
Alma Veil is a medical device that received FDA 510(k) clearance on 2025-05-06. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K251094.
When did Alma Veil receive FDA 510(k) clearance?
Alma Veil received FDA 510(k) clearance on 2025-05-06, under 510(k) number K251094.
Who is the listed applicant for Alma Veil?
The FDA 510(k) record lists Wontech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alma Veil?
The FDA product code for Alma Veil is GEX. This falls under the Gastroenterology category.
列明Wontech Co., Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：GEX）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告