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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 K212478
Device Name Dermatological diode laser system
Applicant
Beijing Stelle Laser Technology Co., Ltd.
Rm.502-1, Tower B, Bldg. 1, Yard 26,
Zhongguancun Medical Device Park, Yongwang W. Rd.
Beijing,  CN 102600
Applicant Contact Zhao Changcheng
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 Received08/09/2021
Decision Date 01/14/2022
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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