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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 K250656
Device Name Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
Applicant
Wuhan Pioon Technology Co., Ltd.
12th Floor, Bldg. 1, Innovative Unit, R&D Center Project,
Marine World Shipyard Park, # 16 Fozuling 3rd Rd., E. L
Wuhan,  CN 430205
Applicant Contact Feng Zhang
Correspondent
Wuhan Pioon Technology Co., Ltd.
12th Floor, Bldg. 1, Innovative Unit, R&D Center Project,
Marine World Shipyard Park, # 16 Fozuling 3rd Rd., E. L
Wuhan,  CN 430205
Correspondent Contact Tracy Liu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/05/2025
Decision Date 04/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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