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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 K260307
Device Name Diode Laser Therapy Systems (V19)
Applicant
Weifang Mingliang Electronics Co., Ltd.
1-301, Bldg. 15, Phase 1, Yuandu Huizhi Industrial Complex
# 3999, Taixiang St.,Weifang Economic Development Zone
Shan Dong,  CN 261000
Applicant Contact MingLiang Li
Correspondent
Weifang Mingliang Electronics Co., Ltd.
1-301, Bldg. 15, Phase 1, Yuandu Huizhi Industrial Complex
# 3999, Taixiang St.,Weifang Economic Development Zone
Shan Dong,  CN 261000
Correspondent Contact MingLiang Li
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/30/2026
Decision Date 04/15/2026
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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