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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 K262426
Device Name Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
Applicant
Wuhan Pioon Technology Co., Ltd.
12th Floor, Bldg. 1, Innovative Unit, R&D Center Project, Ma
# 16 Fozuling 3rd Rd., E. Lake High-Tech Development Zone,
Wuhan,  CN 430205
Applicant Contact Feng Zhang
Correspondent
Wuhan Pioon Technology Co., Ltd.
12th Floor, Bldg. 1, Innovative Unit, R&D Center Project, Ma
# 16 Fozuling 3rd Rd., E. Lake High-Tech Development Zone,
Wuhan,  CN 430205
Correspondent Contact Tracy Liu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/16/2026
Decision Date 09/10/2026
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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