FDA 510(k)

Alma Soprano 鈦金

K 號：K230371 · 2023-02-22

決定日期2023-02-22

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

The Alma Soprano Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K230371. 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 The Alma Soprano Titanium?

The Alma Soprano Titanium is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K230371.

When did The Alma Soprano Titanium receive FDA 510(k) clearance?

The Alma Soprano Titanium received FDA 510(k) clearance on 2023-02-22, under 510(k) number K230371.

Who is the listed applicant for The Alma Soprano Titanium?

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

What is the FDA product code for The Alma Soprano Titanium?

The FDA product code for The Alma Soprano Titanium is GEX. This falls under the Gastroenterology category.

其他以 Alma Lasers, Inc. 為申請人之記錄

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