FDA 510(k)

LED Light Therapy Device, ELIXIR MD

K-Number: K241293 · 2024-07-08

Decision Date2024-07-08

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Device, ELIXIR MD is a medical device manufactured by Yassen Wellness, LLC. It received FDA 510(k) clearance on 2024-07-08 under approval 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.

Frequently Asked Questions

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. It is manufactured by Yassen Wellness, LLC. The 510(k) number is K241293.

When was LED Light Therapy Device, ELIXIR MD approved by the FDA?

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

What company makes LED Light Therapy Device, ELIXIR MD?

LED Light Therapy Device, ELIXIR MD is manufactured by Yassen Wellness, LLC.

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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Official Source

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