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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 K231790
Device Name The InMode System with the Morpheus8 Applicators
Applicant
InMode , Ltd.
Tabor Bldg., Shaar Yokneam Pob 44
Yokneam Illit,  IL 2069200
Applicant Contact Suhair Francis
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/20/2023
Decision Date 07/20/2023
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
Predetermined Change
Control Plan Authorized		 No
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