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FDA 510(k)

IVYLASER 手持式脫毛機

K 號:K230025 · 2023-07-03

決定日期2023-07-03
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

IVYLASER Handhold Hair Removal Machine is the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K230025. 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 IVYLASER Handhold Hair Removal Machine?

IVYLASER Handhold Hair Removal Machine is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K230025.

When did IVYLASER Handhold Hair Removal Machine receive FDA 510(k) clearance?

IVYLASER Handhold Hair Removal Machine received FDA 510(k) clearance on 2023-07-03, under 510(k) number K230025.

Who is the listed applicant for IVYLASER Handhold Hair Removal Machine?

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

What is the FDA product code for IVYLASER Handhold Hair Removal Machine?

The FDA product code for IVYLASER Handhold Hair Removal Machine is OHT.

相關臨床試驗

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其他以 Ivylaser (Beijing) 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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