FDA 510(k)

Cellfina 系統

K 號：K153677 · 2016-02-25

決定日期2016-02-25

產品代碼OUP

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

The Cellfina System is the device name listed in this FDA 510(k) record. The listed applicant is Ulthera, Inc.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K153677. The device is classified under product code OUP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Cellfina System?

The Cellfina System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Ulthera, Inc.. The 510(k) number is K153677.

When did The Cellfina System receive FDA 510(k) clearance?

The Cellfina System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K153677.

Who is the listed applicant for The Cellfina System?

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

What is the FDA product code for The Cellfina System?

The FDA product code for The Cellfina System is OUP.

其他以 Ulthera, 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。

K260618Ulthera® 系統 K250418Ulthera System (UC-1控制單元PRIME型號2.1)K243035Ulthera® 系統 K233996Ulthera System (UC-1 控制單元 PRIME)K192185Cellfina 系統 K180623烏爾特拉系統

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相關器械（代碼：OUP）

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。

K232153AvéliRevelle Aesthetics, Inc.K221336AvéliRevelle Aesthetics, Inc.K212399AveliNc8, Inc.K192185Cellfina 系統Ulthera, Inc.K161885Cellfina 系統Ulthera, Inc.

官方來源

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