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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 K200525
Device Name Medical Diode Laser Hair Removal System
Applicant
Weifang Mingliang Electronics Co., Ltd.
#13426, Yuqing St., High-Tech District
Weifang,  CN 261000
Applicant Contact Li MingLiang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/02/2020
Decision Date 05/27/2020
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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