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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 K250998
Device Name CO2 Laser Therapy System (Model: LFS-D9U)
Applicant
Sanhe Lefis Electronics Co., Ltd.
Bldg. 11 #1-101, Phase 1, Zhongnan High Tech· Yanjiao Sci
Ence And Technology Innovation Smart Valley Industrial Park
Langfang,  CN 065201
Applicant Contact Dandan Wang
Correspondent
Sanhe Lefis Electronics Co., Ltd.
Bldg. 11 #1-101, Phase 1, Zhongnan High Tech· Yanjiao Sci
Ence And Technology Innovation Smart Valley Industrial Park
Langfang,  CN 065201
Correspondent Contact Dandan Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/01/2025
Decision Date 12/19/2025
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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