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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 K210663
Device Name Dermatological Diode Laser Systems
Applicant
Beijing HuaCheng Taike Technology Co., Ltd.
5102p, Floor 1, Bldg. 5, #17 Yunshannanlu Rd.,
Tongzhou I & D Zone, Tongzhou District
Beijing,  CN 101113
Applicant Contact Li Yi
Correspondent
Beijing Believe Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Hui Liu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/05/2021
Decision Date 04/26/2021
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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