FDA 510(k)

波士頓2910（波士頓2910）

K 號：K253245 · 2026-05-21

決定日期2026-05-21

產品代碼GEX

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

Boston 2910 (Boston 2910) 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 2026-05-21 under 510(k) number K253245. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Boston 2910 (Boston 2910)?

Boston 2910 (Boston 2910) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K253245.

When did Boston 2910 (Boston 2910) receive FDA 510(k) clearance?

Boston 2910 (Boston 2910) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K253245.

Who is the listed applicant for Boston 2910 (Boston 2910)?

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 Boston 2910 (Boston 2910)?

The FDA product code for Boston 2910 (Boston 2910) is GEX. This falls under the Gastroenterology category.

其他以 Boston Aesthetics, Inc. 為申請人之記錄

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相關器械（代碼：GEX）

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