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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 Treatment For Cold Sores Herpes Simplex Virus-1
510(k) Number K241155
Device Name Cold Sore Device (QPZ-03)
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 Number878.4860
Classification Product Code
OKJ  
Date Received04/25/2024
Decision Date 09/05/2024
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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