FDA 510(k)

Fraxel® FTX 激光系統

K 號：K242142 · 2024-08-21

決定日期2024-08-21

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

Fraxel® FTX Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K242142. 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 Fraxel® FTX Laser System?

Fraxel® FTX Laser System is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Solta Medical. The 510(k) number is K242142.

When did Fraxel® FTX Laser System receive FDA 510(k) clearance?

Fraxel® FTX Laser System received FDA 510(k) clearance on 2024-08-21, under 510(k) number K242142.

Who is the listed applicant for Fraxel® FTX Laser System?

The FDA 510(k) record lists Solta Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fraxel® FTX Laser System?

The FDA product code for Fraxel® FTX Laser System is GEX. This falls under the Gastroenterology category.

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官方來源

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