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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K241293
Device Name LED Light Therapy Device, ELIXIR MD™
Applicant
Yassen Wellness, LLC
1881 Von Karman Ave.
Suite 1170
Irvine,  CA  92612
Applicant Contact Yassen Ewan
Correspondent
Yassen Wellness, LLC
1881 Von Karman Ave.
Suite 1170
Irvine,  CA  92612
Correspondent Contact Elias Michael
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/08/2024
Decision Date 07/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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