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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 K191855
Device Name EmFace Device
InMode MD Ltd.
Tabor Building, Shaar Yokneam
Yoqneam Illit,  IL 2069200
Applicant Contact Amit Goren
A. Stein - Regulatory Affairs Consulting Ltd.
20 Hata'as Str., Suite 102
Kfar Saba,  IL 4442520
Correspondent Contact Amit Goren
Regulation Number878.4400
Classification Product Code
Date Received07/10/2019
Decision Date 10/29/2019
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