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FDA 510(k)

BLU-U® 藍光光動治療照明器，型號 4170E

K 號：K241358 · 2024-06-13

申請人Sun Pharmaceutical Industries, Inc.
決定日期2024-06-13
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

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is the device name listed in this FDA 510(k) record. The listed applicant is Sun Pharmaceutical Industries, Inc.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K241358. 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 BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is Sun Pharmaceutical Industries, Inc.. The 510(k) number is K241358.

When did BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E receive FDA 510(k) clearance?

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E received FDA 510(k) clearance on 2024-06-13, under 510(k) number K241358.

Who is the listed applicant for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

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

What is the FDA product code for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

The FDA product code for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is GEX. This falls under the Gastroenterology category.

相關臨床試驗

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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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官方來源

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