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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 K140527
Device Name SENSILIGHT MINI
Applicant
El Global Trade, Ltd.
Tzoran 4th St.
Netanya,  IL 42504
Applicant Contact SHLOMIT SEGMAN
Correspondent
El Global Trade, Ltd.
Tzoran 4th St.
Netanya,  IL 42504
Correspondent Contact SHLOMIT SEGMAN
Regulation Number878.4810
Classification Product Code
OHT  
Date Received03/04/2014
Decision Date 07/31/2014
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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