FDA 510(k)

Venus Versa 系統

K 號：K152790 · 2016-01-20

決定日期2016-01-20

產品代碼ONF

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

Venus Versa System is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept , Ltd.. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152790. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Venus Versa System?

Venus Versa System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Venus Concept , Ltd.. The 510(k) number is K152790.

When did Venus Versa System receive FDA 510(k) clearance?

Venus Versa System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152790.

Who is the listed applicant for Venus Versa System?

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

What is the FDA product code for Venus Versa System?

The FDA product code for Venus Versa System is ONF.

其他以 Venus Concept , 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。

K162765金星速度二極體雷射系統 K153717Venus Versa 系統

相關器械（代碼：ONF）

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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