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FDA 510(k)

IPL 髮毛去除器,型號:AP10、AP20、AP30、AP32

K 號:K230021 · 2023-03-31

決定日期2023-03-31
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): AP10, AP20, AP30, AP32 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yangyi Technology ., Ltd.. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K230021. 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): AP10, AP20, AP30, AP32?

IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Shenzhen Yangyi Technology ., Ltd.. The 510(k) number is K230021.

When did IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 receive FDA 510(k) clearance?

IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 received FDA 510(k) clearance on 2023-03-31, under 510(k) number K230021.

Who is the listed applicant for IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32?

The FDA 510(k) record lists Shenzhen Yangyi Technology ., 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(s): AP10, AP20, AP30, AP32?

The FDA product code for IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 is OHT.

相關臨床試驗

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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。

官方來源

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