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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 K212155
Device Name TheraFace LED
Applicant
Theragun, Inc.
6100 Wilshire Blvd., Suite 200
Los Angeles,  CA  90048
Applicant Contact Jaime Sanchez
Correspondent
Schiff & Company, Inc.
583 Mountain Ave.
North Caldwell,  NJ  07006
Correspondent Contact Thomas Padula
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
IRO   OLP  
Date Received07/12/2021
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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