FDA 510(k)

Viveve雷射系統，安全

K 號：K180584 · 2018-04-06

決定日期2018-04-06

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

Viveve RF System, Secure is the device name listed in this FDA 510(k) record. The listed applicant is Viveve, Inc.. It received FDA 510(k) clearance on 2018-04-06 under 510(k) number K180584. 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 Viveve RF System, Secure?

Viveve RF System, Secure is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Viveve, Inc.. The 510(k) number is K180584.

When did Viveve RF System, Secure receive FDA 510(k) clearance?

Viveve RF System, Secure received FDA 510(k) clearance on 2018-04-06, under 510(k) number K180584.

Who is the listed applicant for Viveve RF System, Secure?

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

What is the FDA product code for Viveve RF System, Secure?

The FDA product code for Viveve RF System, Secure is GEI.

其他以 Viveve, Inc. 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。

K213814Viveve 2.0 系統 K162547Viveve 系統

相關器械（代碼：GEI）

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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