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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 K261572
Device Name Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
Applicant
Keyue (Hangzhou) Medical Information Technology Co., Ltd.
Rm. B2210. 2nd Floor, Bldg. (North), #368 Liuhe Rd. Puyan St
Binjiang District
Hangzhou,  CN
Applicant Contact Zhao Li
Correspondent
King Laser Medtech Co.,Ltd
#909 Chenggong Rd., High New Technology Development Zone
Changchun,  CN
Correspondent Contact Jinjing Sui
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/12/2026
Decision Date 10/13/2026
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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