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FDA 510(k)

IPL 髮毛去除器,型號:AI01

K 號:K212897 · 2021-11-04

決定日期2021-11-04
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: AI01 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K212897. 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: AI01?

IPL Hair Removal Device, model: AI01 is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. The 510(k) number is K212897.

When did IPL Hair Removal Device, model: AI01 receive FDA 510(k) clearance?

IPL Hair Removal Device, model: AI01 received FDA 510(k) clearance on 2021-11-04, under 510(k) number K212897.

Who is the listed applicant for IPL Hair Removal Device, model: AI01?

The FDA 510(k) record lists Shenzhen Century Dongyuan 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 Device, model: AI01?

The FDA product code for IPL Hair Removal Device, model: AI01 is OHT.

相關臨床試驗

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其他以 Shenzhen Century Dongyuan 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: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。

官方來源

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