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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 K251435
Device Name InbellaIgnite RF System
Applicant
Inbella Medical, Inc.
100 Leek Crescent, Unit 13
Richmond Hill,  CA L4B 3E6
Applicant Contact Michael Kreindel
Correspondent
Hogan Lovells US LLP
1601 Wewatta St.
Suite #900
Denver,  CO  80202
Correspondent Contact Jodi Scott
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/08/2025
Decision Date 01/27/2026
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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