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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 K212978
Device Name Diode laser therapy system
Applicant
Beijing Unt Technology Co., Ltd.
M2-1 Area, Xinggu Development Zone, Pinggu District
Beijing,  CN 101200
Applicant Contact Qianwen Sheng
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/17/2021
Decision Date 11/10/2021
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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