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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 With Microbeam\Fractional Output
510(k) Number K182498
Device Name Advanced Skin Renewing Device
Applicant
Jiangsu Unimed Laser Technology Co., Ltd.
2f, Bldg. D4, #6, W. Dongsheng Rd.,
High-Tech District
Jiangyin,  CN 214000
Applicant Contact Simon Wang
Correspondent
Jiangsu Unimed Laser Technology Co., Ltd.
2f, Bldg. D4, #6, W. Dongsheng Rd.,
High-Tech District
Jiangyin,  CN 214000
Correspondent Contact Simon Wang
Regulation Number878.4810
Classification Product Code
ONG  
Date Received09/12/2018
Decision Date 11/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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