K253917
- 510(k) number
- K253917
- Device name
- ARION ARC System
- Applicant
- Plasma Surgical, Inc. GA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-04-10
- Date received
- 2025-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253917.pdf
Official FDA record: K253917
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.