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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 K250200
Device Name InbellaBody System
Applicant
Inbella Medical, Inc.
100 Leek Crescent, Unit 13
Richmond Hill,  CA L4B 3E6
Applicant Contact Michael Kreindel
Correspondent
Inbella Medical, Inc.
100 Leek Crescent, Unit 13
Richmond Hill,  CA L4B 3E6
Correspondent Contact Michael Kreindel
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/23/2025
Decision Date 02/11/2025
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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