二極雷射除毛設備
K 號：K180353 · 2018-04-17
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決定日期2018-04-17
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
Diode laser hair removal device is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K180353. 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 Diode laser hair removal device?
Diode laser hair removal device is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K180353.
When did Diode laser hair removal device receive FDA 510(k) clearance?
Diode laser hair removal device received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180353.
Who is the listed applicant for Diode laser hair removal device?
FDA 510(k) 記錄將鄭州PZ雷射瘦身技術有限公司列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for Diode laser hair removal device?
The FDA product code for Diode laser hair removal device is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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其他以 Zhengzhou PZ Laser Slim Technology Co., Ltd. 為申請人之記錄
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。
相關器械（代碼：GEX）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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