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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 K162231
Device Name iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
Applicant
Cyden Limited
Technium 2, Kings Rd.
Swansea,  GB SA1 8PJ
Applicant Contact MIKE KIERNAN
Correspondent
Cyden Limited
Technium 2, Kings Rd.
Swansea,  GB SA1 8PJ
Correspondent Contact MIKE KIERNAN
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
GEX  
Date Received08/08/2016
Decision Date 11/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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