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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 K172181
Device Name micro IPL
Applicant
EL Global Trade Ltd
8 Tzoran St, P.O.Box 8242
Netanya,  IL 4250608
Applicant Contact Yael Liebes
Correspondent
EL Global Trade Ltd
8 Tzoran St, P.O.Box 8242
Netanya,  IL 4250608
Correspondent Contact Yael Liebes
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received07/19/2017
Decision Date 10/13/2017
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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