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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K221571
Device Name InMode Multi-system
Applicant
InMode Ltd.
Tabor Building, Shaar Yokneam
Yokneam Illit,  IL 2069200
Applicant Contact Amit Goren
Correspondent
A. Stein-Regulatory Affairs Consulting Ltd.
18 Hata'as Str., Sute 21
Kfar Saba,  IL 4442518
Correspondent Contact Amit Goren
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
GEI   ISA   NUV   ONF   PBX  
Date Received05/31/2022
Decision Date 06/30/2022
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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