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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 K211735
Device Name CO2 Laser Machine, Model: BW-203B
Applicant
Zhengzhou Bestview ST Co., Ltd.
Rm. 2004, 20f, Lande Center, Huayuan Rd.,
Jinshui District
Zhengzhou,  CN 450000
Applicant Contact Yangchun Jia
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 Received06/07/2021
Decision Date 10/22/2021
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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