FDA 510(k)

LEDライトセラピー装置、ELIXIR MD™

K番号: K241293 · 2024-07-08

決定日2024-07-08

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

LED Light Therapy Device, ELIXIR MD™ is the device name listed in this FDA 510(k) record. The listed applicant is Yassen Wellness, LLC. It received FDA 510(k) clearance on 2024-07-08 under 510(k) number K241293. 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 LED Light Therapy Device, ELIXIR MD™?

LED Light Therapy Device, ELIXIR MD™ is a medical device that received FDA 510(k) clearance on 2024-07-08. The listed applicant is Yassen Wellness, LLC. The 510(k) number is K241293.

When did LED Light Therapy Device, ELIXIR MD™ receive FDA 510(k) clearance?

LED Light Therapy Device, ELIXIR MD™ received FDA 510(k) clearance on 2024-07-08, under 510(k) number K241293.

Who is the listed applicant for LED Light Therapy Device, ELIXIR MD™?

The FDA 510(k) record lists Yassen Wellness, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Device, ELIXIR MD™?

The FDA product code for LED Light Therapy Device, ELIXIR MD™ is GEX. This falls under the Gastroenterology category.

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LEDライトセラピー装置、ELIXIR MD™

医療機器の概要

よくある質問

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関連機器（コード：GEX）

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