FDA 510(k)

輪廓提升器

K 號：K200140 · 2020-03-27

決定日期2020-03-27

產品代碼GAM

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

Silhouette Instalift is the device name listed in this FDA 510(k) record. The listed applicant is Silhouette Lift, Inc.. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K200140. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Silhouette Instalift?

Silhouette Instalift is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Silhouette Lift, Inc.. The 510(k) number is K200140.

When did Silhouette Instalift receive FDA 510(k) clearance?

Silhouette Instalift received FDA 510(k) clearance on 2020-03-27, under 510(k) number K200140.

Who is the listed applicant for Silhouette Instalift?

The FDA 510(k) record lists Silhouette Lift, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silhouette Instalift?

The FDA product code for Silhouette Instalift is GAM.

其他以 Silhouette Lift, Inc. 為申請人之記錄

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相關器械（代碼：GAM）

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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