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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 K233642
Device Name InMode RF System
Applicant
Inmode , Ltd.
Tabor Bldg., Shaar Yokneam Pob 44,
Yokneam Iillit,  IL 2069200
Applicant Contact Suhair Francis
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/13/2023
Decision Date 03/20/2024
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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