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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K242977
Device Name 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou,  CN 221004
Applicant Contact Che Gang
Correspondent
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou,  CN 221004
Correspondent Contact Che Gang
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/26/2024
Decision Date 02/06/2025
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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