FDA 510(k)

Ulthera® 系統

K 號：K243035 · 2025-02-24

決定日期2025-02-24

產品代碼OHV

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

Ulthera® 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 2025-02-24 under 510(k) number K243035. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ulthera® System?

Ulthera® System is a medical device that received FDA 510(k) clearance on 2025-02-24. The listed applicant is Ulthera, Inc.. The 510(k) number is K243035.

When did Ulthera® System receive FDA 510(k) clearance?

Ulthera® System received FDA 510(k) clearance on 2025-02-24, under 510(k) number K243035.

Who is the listed applicant for Ulthera® 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 Ulthera® System?

The FDA product code for Ulthera® System is OHV.

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)K233996Ulthera System (UC-1 控制單元 PRIME)K192185Cellfina 系統 K180623烏爾特拉系統 K161885Cellfina 系統

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相關器械（代碼：OHV）

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Ulthera, Inc.K250418Ulthera System (UC-1控制單元PRIME型號2.1)Ulthera, Inc.K240687SofWave系統Sofwave Medical, Ltd.K233996Ulthera System (UC-1 控制單元 PRIME)Ulthera, Inc.K233104SofWave系統Sofwave Medical, Ltd.K232455SofWave系統Sofwave Medical, Ltd.

官方來源

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