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FDA 510(k)

LED Light Therapy Device, ELIXIR MD™

K-Number: K241293 · 2024-07-08

ApplicantYassen Wellness, LLC
Decision Date2024-07-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07676643ELIXIR MDTM Satisfaction Clinical TrialACTIVE_NOT_RECRUITING

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Official Source

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