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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, vacuum, radio frequency induced heat
510(k) Number K153568
Device Name InMode Plus System
Applicant
InMode MD Ltd.
Tabor Building, Shaar Yokneam, POB 44
yoqneam,  IL 20692
Applicant Contact ahava stein
Correspondent
A. STEIN- REGULATORY AFFAIRS CONSULTING LTD.
20 HATA'AS STR., SUITE 102
kfar saba,  IL 44425
Correspondent Contact ahava stein
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
ISA  
Date Received12/14/2015
Decision Date 07/12/2016
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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