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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 K251801
Device Name Diode laser device (BM091)
Applicant
Hebei Newangie Technology Co., Ltd.
# 509, Taihang S. St., High-Tech Zone, Shijiazhuang
City, Hebei Province Rm. 402, Bldg. A-5, Guoxietang
Shijiazhuang,  CN 050035
Applicant Contact Ning Wang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5
Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Wang Ray
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/12/2025
Decision Date 08/08/2025
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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