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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 K210954
Device Name Synergy
Applicant
Yrs Group, Inc.
4480 Delancey Dr. Suite 14
Las Vegas,  NV  89103
Applicant Contact Doris Dong
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number878.4810
Classification Product Code
OHS  
Date Received03/30/2021
Decision Date 06/29/2021
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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