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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 K261562
Device Name Diode Laser Therapy System
Applicant
Sanhe LEFIS Electronics Co., Ltd.
Bldg. 11 #1-101, Phase 1
Zhongnan High Tech Yanjiao Science And Technology Innovation
Langfang,  CN 065201
Applicant Contact Dandan Wang
Correspondent
Sanhe LEFIS Electronics Co., Ltd.
Bldg. 11 #1-101, Phase 1
Zhongnan High Tech Yanjiao Science And Technology Innovation
Langfang,  CN 065201
Correspondent Contact Dandan Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/11/2026
Decision Date 09/10/2026
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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