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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K210948
Device Name Omnilux CLEAR
Applicant
Globalmed Technologies
163 Camino Dorado, Suite B
Napa,  CA  94558
Applicant Contact Lisa Thorson
Correspondent
Globalmed Technologies
163 Camino Dorado, Suite B
Napa,  CA  94558
Correspondent Contact Lisa Thorson
Regulation Number878.4810
Classification Product Code
OLP  
Date Received03/30/2021
Decision Date 06/24/2021
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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