Manufacturer
Plasma Surgical, Inc.ARION ARC System
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253917
- Device name
- ARION ARC System
- Company
- Plasma Surgical, Inc.
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-12-08
- Decision date
- 2026-04-10
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- Surgery
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The ARION Argon Reposable Coagulator (ARC) System is a plasma surgery system intended for coagulation in open surgery.
Intended Use
The ARION Argon Reposable Coagulator (ARC) System is a plasma surgery system intended for coagulation in open surgery.
Device Description
The ARION ARC System is a plasma surgery system that utilizes medical-grade high-purity argon gas (≥99.998%) with a flow rate of 0.2-0.7 l/min. It operates on an energy source of 30-60V DC within the handpiece, with activation achieved through a handpiece button or footswitch. The system allows for tissue penetration depth typically up to 2.5mm and power settings ranging from 20-170W, with a maximum of 300W. The handpiece is designed to be reposable, with electrode components capable of a minimum of 30 uses, each lasting 5 minutes. The system includes a fully enclosed umbilical cable for wipe down capability and features a user interface with multiple stages for system startup, session and power level selection, and cooldown/shutdown. Accessories include an ARC Footswitch, Handpiece Holder, and Side Basket. The handpieces are sterile, single-use, with a shelf-life of 3 years.
Summary parsed at:2026-06-19 23:53:39 UTC
Predicate devices
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K253917 references 1 predicate/reference device
Cited as predicate
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