FDA 510(k)

Epilaser Pro

K号: K233224 · 2024-01-27

申请人Epilady 2000, LLC

决定日期2024-01-27

产品代码GEX

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决定实质等同

器械摘要

Epilaser Pro 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 2024-01-27 under 510(k) number K233224. 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 Pro?

Epilaser Pro is a medical device that received FDA 510(k) clearance on 2024-01-27. The listed applicant is Epilady 2000, LLC. The 510(k) number is K233224.

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

Epilaser Pro received FDA 510(k) clearance on 2024-01-27, under 510(k) number K233224.

Who is the listed applicant for Epilaser Pro?

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 Pro?

The FDA product code for Epilaser Pro 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。

K213105Epilaser Absolute K170970Epilaser

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