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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 K192735
Device Name Diode Laser Hair Removal Machine
Applicant
Beijing Lead Beauty S & T Co., Ltd.
202, #5 Workshop, #1 Caida 3rd Rd. Nancai
Shunyi Distri
Beijing,  CN 101300
Applicant Contact Jiao Zhang
Correspondent
Mid-Link Consultinf Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/27/2019
Decision Date 04/03/2020
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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