FDA 510(k)

IVYLASER 二極雷射脫毛系統（IVY-HR-Alloy）

K 號：K240611 · 2024-06-20

申請人Ivylaser (Beijing) Technology Co.,Ltd

決定日期2024-06-20

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

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240611. 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 IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K240611.

When did IVYLASER Diode laser hair removal system (IVY-HR-Alloy) receive FDA 510(k) clearance?

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240611.

Who is the listed applicant for IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

The FDA 510(k) record lists Ivylaser (Beijing) Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

The FDA product code for IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is GEX. This falls under the Gastroenterology category.

其他以 Ivylaser (Beijing) Technology Co.,Ltd 為申請人之記錄

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相關器械（代碼：GEX）

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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