ARION ARC System— 510(k) K253917
Substantially EquivalentPlasma Surgical, Inc.
FDA 510(k) clearance K253917 for ARION ARC System, Substantially Equivalent on 2026-04-10. Applicant: Plasma Surgical, Inc.. Device class: 2.
Summary
The ARION ARC System is from Plasma Surgical. It's filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't describe the system.
Class II, 21 CFR 878.4400. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Plasma Surgical filed from Roswell, Georgia. Review took 123 days (December 8, 2025 to April 10, 2026).
Clearance details
- Applicant
- Plasma Surgical, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roswell, GA, US
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Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.