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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K232709
Device Name Diode laser therapy device
Applicant
Hebei Zhemai Technology Co., Ltd.
1st Floor, N Of #1 Warehouse, W Of Shuichang Rd., N Of Beiyi
Rd, Yanjiao Development Zone, Sanhe
Langfang,  CN 065201
Applicant Contact Yuting Qu
Correspondent
Hebei Zhemai Technology Co., Ltd.
1st Floor, N Of #1 Warehouse, W Of Shuichang Rd., N Of Beiyi
Rd, Yanjiao Development Zone, Sanhe
Langfang,  CN 065201
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/05/2023
Decision Date 11/30/2023
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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