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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 K210968
Device Name reVive Light Therapy Essentials
Applicant
Led Technologies, Inc.
12821 Starkey Rd., Suite 4900
Largo,  FL  33773
Applicant Contact Lloyd Nelson
Correspondent
Led Technologies, Inc.
12821 Starkey Rd., Suite 4900
Largo,  FL  33773
Correspondent Contact Jelena Barbaric
Regulation Number878.4810
Classification Product Code
OLP  
Date Received03/31/2021
Decision Date 12/21/2021
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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