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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 K253829
Device Name Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
Applicant
Beijing HuaCheng Taike Technology Co., Ltd.
Rm. 402, 4th Floor, Bldg. 4, Courtyard 5, S. Third St.
Huoxian Town, Tongzhou District
Beijing,  CN 101113
Applicant Contact Wang Peng
Correspondent
Tianjin Xinnuocheng Medical Technology Co., LTD.
Rm. 1505, Wanhai Bldg., Dazhigu Sub-District
Hedong District
Tianjin,  CN 300170
Correspondent Contact Lena Zhang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/01/2025
Decision Date 02/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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