FDA 510(k)

家用IPL美容設備

K 號：K180016 · 2018-03-20

決定日期2018-03-20

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

Home Use IPL Beauty Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mismon Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-03-20 under 510(k) number K180016. 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 Home Use IPL Beauty Device?

Home Use IPL Beauty Device is a medical device that received FDA 510(k) clearance on 2018-03-20. The listed applicant is Shenzhen Mismon Technology Co., Ltd.. The 510(k) number is K180016.

When did Home Use IPL Beauty Device receive FDA 510(k) clearance?

Home Use IPL Beauty Device received FDA 510(k) clearance on 2018-03-20, under 510(k) number K180016.

Who is the listed applicant for Home Use IPL Beauty Device?

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

What is the FDA product code for Home Use IPL Beauty Device?

The FDA product code for Home Use IPL Beauty Device is OHT.

其他以 Shenzhen Mismon 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。

K210311家用IPL美妝設備，型號：MS-208B、MS-212B、MS-216B、MS-218B、MELSYA-M6、MELSYA-M7。

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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官方來源

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