FDA 510(k)

Q閃脈式 Neodymium:YAG 激光機

K 號：K193609 · 2020-03-20

決定日期2020-03-20

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

Q Switched Nd: YAG Laser machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Lead Beauty S & T Co., Ltd.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K193609. 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 Q Switched Nd: YAG Laser machine?

Q Switched Nd: YAG Laser machine is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Beijing Lead Beauty S & T Co., Ltd.. The 510(k) number is K193609.

When did Q Switched Nd: YAG Laser machine receive FDA 510(k) clearance?

Q Switched Nd: YAG Laser machine received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193609.

Who is the listed applicant for Q Switched Nd: YAG Laser machine?

The FDA 510(k) record lists Beijing Lead Beauty S & T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Switched Nd: YAG Laser machine?

The FDA product code for Q Switched Nd: YAG Laser machine is GEX. This falls under the Gastroenterology category.

其他以 Beijing Lead Beauty S & T Co., Ltd. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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