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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 K122280
Device Name IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
Applicant
CYDEN LIMITED
2001 PENNSYLANIA AVE
SUITE 950
WASHINGTON,  DC  20006
Applicant Contact AUSTIN SPEIER
Correspondent
CYDEN LIMITED
2001 PENNSYLANIA AVE
SUITE 950
WASHINGTON,  DC  20006
Correspondent Contact AUSTIN SPEIER
Regulation Number878.4810
Classification Product Code
OHT  
Date Received07/30/2012
Decision Date 10/23/2012
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
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