FDA 510(k)

IPL 髮毛去除器，型號：JP1、JR3、JR8、JR9

K 號：K231800 · 2023-09-07

決定日期2023-09-07

產品代碼OHT

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

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K231800. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9?

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. The 510(k) number is K231800.

When did IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 receive FDA 510(k) clearance?

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231800.

Who is the listed applicant for IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9?

FDA 510(k) 記錄將深圳千宇科技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 IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9?

The FDA product code for IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 is OHT.

其他以 Shenzhen Qianyu 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。

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相關器械（代碼：OHT）

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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