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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 K242151
Device Name Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
Applicant
Shenzhen Nuon Medical Equipment Co., Ltd.
1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St.,
Baoan Dist,
Shenzhen,  CN 518000
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Nuon Medical Equipment Co., Ltd.
1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St.,
Baoan Dist,
Shenzhen,  CN 518000
Correspondent Contact Alain Dijkstra
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received07/23/2024
Decision Date 04/08/2025
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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