FDA 510(k)

InMode 系統搭配 Morpheus8 (Fractora) 應用器

K 號：K192695 · 2019-12-27

決定日期2019-12-27

產品代碼GEI

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

InMode System with the Morpheus8 (Fractora) Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192695. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InMode System with the Morpheus8 (Fractora) Applicators?

InMode System with the Morpheus8 (Fractora) Applicators is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K192695.

When did InMode System with the Morpheus8 (Fractora) Applicators receive FDA 510(k) clearance?

InMode System with the Morpheus8 (Fractora) Applicators received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192695.

Who is the listed applicant for InMode System with the Morpheus8 (Fractora) Applicators?

The FDA 510(k) record lists Inmode MD , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InMode System with the Morpheus8 (Fractora) Applicators?

The FDA product code for InMode System with the Morpheus8 (Fractora) Applicators is GEI.

其他以 Inmode MD , 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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