FDA 510(k)

IPL 髮毛脫除機

K 號：K213020 · 2021-12-16

決定日期2021-12-16

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 machine is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Borria Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213020. 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 machine?

IPL hair removal machine is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Shenzhen Borria Technology Co., Ltd.. The 510(k) number is K213020.

When did IPL hair removal machine receive FDA 510(k) clearance?

IPL hair removal machine received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213020.

Who is the listed applicant for IPL hair removal machine?

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

What is the FDA product code for IPL hair removal machine?

The FDA product code for IPL hair removal machine is OHT.

其他以 Shenzhen Borria 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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官方來源

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