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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K192695
Device Name InMode System with the Morpheus8 (Fractora) Applicators
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 Received09/26/2019
Decision Date 12/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No