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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K180383
Device Name Light based hair removal device
Applicant
Shenzhen Gsd Tech Co., Ltd.
Bldg. A Junsd Hi-Tech Park, W. Of Bao'An Rd.
Watch & Clock Base, Guangming District
Shenzhen,  CN 518106
Applicant Contact Ziyi Gui
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center
Guimiao Rd., S
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received02/12/2018
Decision Date 05/11/2018
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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