Alma二极管台式激光器
K号: K160952 · 2016-05-05
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器械摘要
Alma Diode Tabletop Laser is the device name listed in this FDA 510(k) record. The listed applicant is Alma, Ltd.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K160952. 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 Diode Tabletop Laser?
Alma Diode Tabletop Laser is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Alma, Ltd.. The 510(k) number is K160952.
When did Alma Diode Tabletop Laser receive FDA 510(k) clearance?
Alma Diode Tabletop Laser received FDA 510(k) clearance on 2016-05-05, under 510(k) number K160952.
Who is the listed applicant for Alma Diode Tabletop Laser?
The FDA 510(k) record lists Alma, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alma Diode Tabletop Laser?
The FDA product code for Alma Diode Tabletop Laser is GEX. This falls under the Gastroenterology category.
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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。
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官方来源
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