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FDA 510(k)

Unicorn+ 電波系統（Unicorn+）；Unicorn+ 電波系統（Unicorn+ I）；Unicorn+ 電波系統（Unicorn+ II）；Unicorn+ 電波系統（Unicorn+ III）

K 號：K241832 · 2025-02-13

申請人Boston Aesthetics, Inc.
決定日期2025-02-13
產品代碼GEI
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

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K241832. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)?

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K241832.

When did Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) receive FDA 510(k) clearance?

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) received FDA 510(k) clearance on 2025-02-13, under 510(k) number K241832.

Who is the listed applicant for Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)?

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

What is the FDA product code for Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)?

The FDA product code for Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) is GEI.

相關臨床試驗

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