凜酷雕塑精英系統
K 號：K233732 · 2024-09-12
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決定日期2024-09-12
產品代碼OOK
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
CoolSculpting Elite System is the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K233732. The device is classified under product code OOK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CoolSculpting Elite System?
CoolSculpting Elite System is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics. The 510(k) number is K233732.
When did CoolSculpting Elite System receive FDA 510(k) clearance?
CoolSculpting Elite System received FDA 510(k) clearance on 2024-09-12, under 510(k) number K233732.
Who is the listed applicant for CoolSculpting Elite System?
The FDA 510(k) record lists Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoolSculpting Elite System?
The FDA product code for CoolSculpting Elite System is OOK.
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相關器械（代碼：OOK）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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