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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 K262070
Device Name Diode Laser Therapy Systems (DL612A)
Applicant
Hebei Zollvan Medical Technology Co., Ltd.
#201,3rd Bldg., Zhidian Industrial Park, #999 Fuxing E. Rd.,
Lianchi District
Baoding,  CN 071030
Applicant Contact Zhichao Ma
Correspondent
Tianjin Xinnuocheng Medical Technology Co., Ltd.
Rm. 1505, Wanhai Bldg., Dazhigu Sub-District
Hedong District
Tianjin,  CN 300170
Correspondent Contact Liya Meng
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/22/2026
Decision Date 08/19/2026
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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