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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 K252658
Device Name Medical Diode Laser Systems (TR-B)
Applicant
Baoding Te'Anzhou Electronic Technology Co., Ltd.
Rm. 1702, 17th Floor, Zhibo Technology Comprehensive
Research And Development Bldg., #89, Hengbin Rd.
Baoding,  CN 071025
Applicant Contact Wenjia Shang
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lujiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/22/2025
Decision Date 11/28/2025
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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