FDA 510(k)

BLU-U® 藍色光光動性療法照明器、モデル4170E

K番号: K241358 · 2024-06-13

決定日2024-06-13

製品コードGEX

諮問委員会SU

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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.

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BLU-U® 藍色光光動性療法照明器、モデル4170E

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEX）

公式ソース