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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 Bldg., Shaar Yokneam
Pob 44
Yokneam,  IL 20692
Applicant Contact Ahava Stein
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
20 Hata'As St., 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
Predetermined Change
Control Plan Authorized		 No
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