FDA 510(k)

Youlaser PRIME；Youlaser PRIME CO2；Youlaser PRIME MT

K 號：K241092 · 2024-10-10

決定日期2024-10-10

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

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K241092. 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 Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT?

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Quanta System Spa. The 510(k) number is K241092.

When did Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT receive FDA 510(k) clearance?

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT received FDA 510(k) clearance on 2024-10-10, under 510(k) number K241092.

Who is the listed applicant for Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT?

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

What is the FDA product code for Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT?

The FDA product code for Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT is GEX. This falls under the Gastroenterology category.

其他以 Quanta System Spa 為申請人之記錄

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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。

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