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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
Applicant
Inmode MD Ltd.
Tabor Building, Shaar Yokneam
Yoqneam Illit,  IL 2069200
Applicant Contact Amit Goren
Correspondent
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
GEI  
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
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