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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 K243993
Device Name Photon Therapy Apparatus (BL-10)
Applicant
Xemis Medical Technology (Shenzhen) Co., Ltd.
1101/1102/1201/1202, Unit 1, Bldg. 2, Hongpeng Bldg.,
Tiegang Community, Xixiang St., Baoan
Shenzhen,  CN 518102
Applicant Contact Yongfen Yang
Correspondent
Xemis Medical Technology (Shenzhen) Co., Ltd.
1101/1102/1201/1202, Unit 1, Bldg. 2, Hongpeng Bldg.,
Tiegang Community, Xixiang St., Baoan
Shenzhen,  CN 518102
Correspondent Contact Yongfen Yang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/26/2024
Decision Date 03/13/2025
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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