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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 K230274
Device Name Medical Diode Laser (M2)
Applicant
Wuhan Pioon Technology Co., Ltd.
7th Floor, A21 Of Sino Pharm Bldg., Biolake Innovation
Park, # 666 Gaoxin Ave.
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.
Wuhan,  CN 430075
Correspondent Contact Feng Zhang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/01/2023
Decision Date 03/31/2023
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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