FDA 510(k)

Ulthera System (UC-1 控制單元 PRIME)

K 號：K233996 · 2024-02-22

決定日期2024-02-22

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 (UC-1 Control Unit PRIME) is the device name listed in this FDA 510(k) record. The listed applicant is Ulthera, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K233996. 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 (UC-1 Control Unit PRIME)?

Ulthera System (UC-1 Control Unit PRIME) is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Ulthera, Inc.. The 510(k) number is K233996.

When did Ulthera System (UC-1 Control Unit PRIME) receive FDA 510(k) clearance?

Ulthera System (UC-1 Control Unit PRIME) received FDA 510(k) clearance on 2024-02-22, under 510(k) number K233996.

Who is the listed applicant for Ulthera System (UC-1 Control Unit PRIME)?

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 (UC-1 Control Unit PRIME)?

The FDA product code for Ulthera System (UC-1 Control Unit PRIME) 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)K243035Ulthera® 系統 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.K243035Ulthera® 系統Ulthera, Inc.K240687SofWave系統Sofwave Medical, Ltd.K233104SofWave系統Sofwave Medical, Ltd.K232455SofWave系統Sofwave Medical, Ltd.

官方來源

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