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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 K143003
Device Name iPulse Smooth Skin Gold Hair Removal System
Applicant
Ipulse Limited
Technium 2, Kings Rd., The Docks
Swansea,  GB Sa1 8pJ
Applicant Contact Mike Kiernan
Correspondent
Ipulse Limited
Technium 2, Kings Rd., The Docks
Swansea,  GB Sa1 8pJ
Correspondent Contact Mike Kiernan
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Codes
GEX   ONF  
Date Received10/20/2014
Decision Date 06/18/2015
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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