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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 K252447
Device Name Picosecond laser device (BMPS4)
Applicant
Hebei Newangie Technology Co., Ltd.
Rm. 402, Bldg. A-5, Guoxietang Industrial Park, # 509,
Taihang S. St., High-Tech Zone
Shijiazhuang City,  CN 050035
Applicant Contact Ning Wang
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/04/2025
Decision Date 10/01/2025
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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