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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 K130315
Device Name IPULSE HAIR REMOVAL SYSTEM
Applicant
Cyden Limited
Technium 2, Kings Rd.
Swansea, West Glamorgan,  GB SA1 8PJ
Applicant Contact DAVID BRODERICK
Correspondent
Cyden Limited
Technium 2, Kings Rd.
Swansea, West Glamorgan,  GB SA1 8PJ
Correspondent Contact DAVID BRODERICK
Regulation Number878.4810
Classification Product Code
OHT  
Date Received02/08/2013
Decision Date 07/12/2013
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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