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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K251034
Device Name Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
Applicant
Shenzhen Nuon Medical Equipment Co., Ltd.
1st Floor-3rd Floor,# 27-2,Xintang Rd.,Xintian Community
Fuhai St.,Baoan District
Shenzhen,  CN 518000
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Nuon Medical Equipment Co., Ltd.
1st Floor-3rd Floor,# 27-2,Xintang Rd.,Xintian Community
Fuhai St.,Baoan District
Shenzhen,  CN 518000
Correspondent Contact Anna He
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Codes
OHS   OLP  
Date Received04/03/2025
Decision Date 10/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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