FDA 510(k)

醫用二極雷射脫毛系統

K 號：K200525 · 2020-05-27

申請人Weifang Mingliang Electronics Co., Ltd.

決定日期2020-05-27

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Medical Diode Laser Hair Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Weifang Mingliang Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K200525. 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.

常見問題

What is the Medical Diode Laser Hair Removal System?

Medical Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Weifang Mingliang Electronics Co., Ltd.. The 510(k) number is K200525.

When did Medical Diode Laser Hair Removal System receive FDA 510(k) clearance?

Medical Diode Laser Hair Removal System received FDA 510(k) clearance on 2020-05-27, under 510(k) number K200525.

Who is the listed applicant for Medical Diode Laser Hair Removal System?

The FDA 510(k) record lists Weifang Mingliang Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Diode Laser Hair Removal System?

The FDA product code for Medical Diode Laser Hair Removal System is GEX. This falls under the Gastroenterology category.

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