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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 K251457
Device Name Diode laser therapy device (VADER)
Applicant
Beijing Superlaser Technology Co., Ltd.
2 Floor,Bldg.3, #2 Zhongfu St., Xihongmen Town
Daxing District
Beijing,  CN 100076
Applicant Contact Shuang Shi
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 Received05/12/2025
Decision Date 09/03/2025
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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