FDA 510(k)

truSculpt

K 號：K162512 · 2016-12-09

決定日期2016-12-09

產品代碼PBX

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

truSculpt is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162512. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the truSculpt?

truSculpt is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Cutera, Inc.. The 510(k) number is K162512.

When did truSculpt receive FDA 510(k) clearance?

truSculpt received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162512.

Who is the listed applicant for truSculpt?

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

What is the FDA product code for truSculpt?

The FDA product code for truSculpt is PBX.

其他以 Cutera, 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。

K251149AviClear 激光系統 K233237xeo+ 家族 K230660AviClear 激光系統 K223110truSculpt iD K221407truSculpt iD K213461AviClear 激光系統

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相關器械（代碼：PBX）

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。

K243223多療法美容治療設備（BHS 202 UNYQUE）Bh Group Us, LLC K253480Capenergy C 裝置 RF C200 及 C400 DrakarianCapenergy Medical S.L.K260647規範化醫療設備名稱：SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV 裝置Pollogen, Ltd.

官方來源

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