FDA 510(k)

Venus Nova (FP-2001)

K 號：K252845 · 2025-11-06

決定日期2025-11-06

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

Venus Nova (FP-2001) is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K252845. 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 Venus Nova (FP-2001)?

Venus Nova (FP-2001) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Venus Concept, Inc.. The 510(k) number is K252845.

When did Venus Nova (FP-2001) receive FDA 510(k) clearance?

Venus Nova (FP-2001) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252845.

Who is the listed applicant for Venus Nova (FP-2001)?

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

What is the FDA product code for Venus Nova (FP-2001)?

The FDA product code for Venus Nova (FP-2001) is GEI.

其他以 Venus Concept, Inc. 為申請人之記錄

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K232192Venus Versa PRO 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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