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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 K211977
Device Name Medical Diode Laser Systems
Applicant
Wuhan Dimed Laser Technology Co., Ltd.
Rm. 311, 313, 315, Hubei Guozhi Patent Venture Incubator
Bldg., 327-1 Minzu Ave.
Wuhan,  CN 430223
Applicant Contact Qiao Cheng
Correspondent
Shenzhen Hlongmed Biotech Co., Ltd.
1201, Haosheng Business Center, 4096 Dongbin Rd., Nanshan
Shenzhen,  CN 518054
Correspondent Contact Long Yang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/25/2021
Decision Date 10/26/2021
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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