K253917
Substantially EquivalentARION ARC System
The ARION ARC System is a plasma-based surgical energy system — Plasma Surgical has a cleared argon-plasma coagulation platform, and "ARC" in the naming aligns with their PlasmaJet lineage. Product code GEI covers electrosurgical cutting and coagulation devices; plasma and argon-enhanced coagulation tools are cleared under this code alongside conventional electrosurgery.
General, Plastic Surgery panel, Traditional 510(k). Plasma/argon coagulation systems have a defined predicate lineage in GEI and clearances typically turn on comparison to the applicant's own prior device or to major incumbents like ConMed (Beamer/Argon II) or Erbe.
Plasma Surgical, Inc. files from Roswell, GA. Four-month review clock.
- Applicant
- Plasma Surgical, Inc.
- Product code
- GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roswell, GA, US
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.