FDA 510(k)

Epilaser Absolute

K号: K213105 · 2022-12-13

申请人Epilady 2000, LLC

决定日期2022-12-13

产品代码GEX

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决定实质等同

器械摘要

Epilaser Absolute is the device name listed in this FDA 510(k) record. The listed applicant is Epilady 2000, LLC. It received FDA 510(k) clearance on 2022-12-13 under 510(k) number K213105. 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 Epilaser Absolute?

Epilaser Absolute is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Epilady 2000, LLC. The 510(k) number is K213105.

When did Epilaser Absolute receive FDA 510(k) clearance?

Epilaser Absolute received FDA 510(k) clearance on 2022-12-13, under 510(k) number K213105.

Who is the listed applicant for Epilaser Absolute?

The FDA 510(k) record lists Epilady 2000, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epilaser Absolute?

The FDA product code for Epilaser Absolute is GEX. This falls under the Gastroenterology category.

列明Epilady 2000, LLC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。

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