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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K223482
Device Name reVive Light Therapy® Wrinkle and Acne LED Device
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
OHS  
Subsequent Product Code
OLP  
Date Received11/18/2022
Decision Date 12/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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