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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 K253917
Device Name ARION ARC System
Applicant
Plasma Surgical, Inc.
1125 Northmeadow Pkwy.
Suite 100
Roswell,  GA  30076
Applicant Contact Rupanshi Naik
Correspondent
Pathmaker FDA Law, PLLC
1415 Lilac Dr. N
Suite 270
Minneapolis,  MN  55422
Correspondent Contact Amy Fowler
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/08/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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