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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K261204
Device Name Intense Pulsed Light Therapy Device
Applicant
Sanhe LEFIS Electronics Co., Ltd.
Bldg. 11 #1-101, Phase 1, Zhongnan High Tech Yanjiao Science
Technology Innovation Smart Valley Industrial Park 1
Langfang,  CN 065201
Applicant Contact Dandan Wang
Correspondent
Sanhe LEFIS Electronics Co., Ltd.
Bldg. 11 #1-101, Phase 1, Zhongnan High Tech Yanjiao Science
Technology Innovation Smart Valley Industrial Park 1
Langfang,  CN 065201
Correspondent Contact Dandan Wang
Regulation Number878.4810
Classification Product Code
ONF  
Date Received04/13/2026
Decision Date 06/12/2026
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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