FDA 510(k)

奈秒YAG激光治療系統

K 號：K193477 · 2020-06-24

申請人Beijing Kes Biology Technology Co., Ltd.

決定日期2020-06-24

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

Nd: YAG Laser Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Kes Biology Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-24 under 510(k) number K193477. 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 Nd: YAG Laser Therapy Systems?

Nd: YAG Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2020-06-24. The listed applicant is Beijing Kes Biology Technology Co., Ltd.. The 510(k) number is K193477.

When did Nd: YAG Laser Therapy Systems receive FDA 510(k) clearance?

Nd: YAG Laser Therapy Systems received FDA 510(k) clearance on 2020-06-24, under 510(k) number K193477.

Who is the listed applicant for Nd: YAG Laser Therapy Systems?

The FDA 510(k) record lists Beijing Kes Biology Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nd: YAG Laser Therapy Systems?

The FDA product code for Nd: YAG Laser Therapy Systems is GEX. This falls under the Gastroenterology category.

其他以 Beijing Kes Biology Technology 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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