FDA 510(k)

LUNE PureHygiene

K号: K260138 · 2026-05-29

决定日期2026-05-29

产品代码GEX

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决定实质等同

器械摘要

LUNE PureHygiene is the device name listed in this FDA 510(k) record. The listed applicant is Enamel Pure. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K260138. 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 LUNE PureHygiene?

LUNE PureHygiene is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Enamel Pure. The 510(k) number is K260138.

When did LUNE PureHygiene receive FDA 510(k) clearance?

LUNE PureHygiene received FDA 510(k) clearance on 2026-05-29, under 510(k) number K260138.

Who is the listed applicant for LUNE PureHygiene?

The FDA 510(k) record lists Enamel Pure as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUNE PureHygiene?

The FDA product code for LUNE PureHygiene is GEX. This falls under the Gastroenterology category.

列明Enamel Pure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。

K234085LUNE™ PureHygiene

官方来源

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