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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 K240644
Device Name Medical Diode Laser (S1Pro)
Applicant
Wuhan Pioon Technology Co., Ltd.
7th Floor,A21 Of Sino Pharm Bldg., Biolake Innovation
Park,#666 Gaoxin Ave.,East Lake High-Tech Development
Wuhan,  CN 430075
Applicant Contact Feng Zhang
Correspondent
Wuhan Pioon Technology Co., Ltd.
7th Floor,A21 Of Sino Pharm Bldg., Biolake Innovation
Park,#666 Gaoxin Ave.,East Lake High-Tech Development
Wuhan,  CN 430075
Correspondent Contact Tracy Liu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/07/2024
Decision Date 06/10/2024
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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