FDA.reportPublic FDA data

ARION

Primary DI
M397PS104130
Brand
ARION
Company
PLASMA SURGICAL, INC
Model
PS10-4130
Catalog number
PS10-4130
Device description
ARC Generator
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253917000ARION ARC SystemPlasma Surgical, Inc.2026-04-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M397PS104130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Plasma surgical system handpieceA hand-held instrument used with a plasma surgical system control unit to coagulate, cut, and/or vaporize/ablate tissue during open and/or laparoscopic surgery. Inert argon (Ar) gas is excited (ionized) in the instrument by a series of internal bipolar electrodes to generate plasma (atomic ions and free electrons) which emerges from the tip of the handpiece in a stream to release kinetic and thermal energy upon contact with tissue. Operation is regulated using a hand-control on the instrument or via a connected foot-switch. The instrument is typically in the form of a pen/pencil with attached cables for connection to the control unit. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight25Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature39 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
6785784390rbou@plasmasurgical.com

Regulatory Flags#

DUNS number
360799048
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M397PS102130PlasmaJet Neutral Plasma Surgery SystemPS10-2130PS10-21302026-05-06
M397PS103130PlasmaJet Neutral Plasma Surgery SystemPS10-3130PS10-31302026-05-06
M3970SCP0512H0PlasmaJet Neutral Plasma Surgery SystemOS-CP 05-12HOS-CP 05-12H2016-07-18
M397LSCG0528H0PlasmaJet Neutral Plasma Surgery SystemLS-CG 05-28HLS-CG 05-28H2016-07-18
M397LSCP0528H0PlasmaJet Neutral Plasma Surgery SystemLS-CP 05-28HLS-CP 05-28H2016-07-18
M397OSCG05070PlasmaJet Neutral Plasma Surgery SystemOS-CG-05-07OS-CG-05-072018-10-01
M397OSCG0507H0PlasmaJet Neutral Plasma Surgery SystemOS-CG 05-07HOS-CG 05-07H2016-07-18
M397OSCG0512H0PlasmaJet Neutral Plasma Surgery SystemOS-CG 05-12HOS-CG 05-12H2016-07-18
M397OSCP0507H0PlasmaJet Neutral Plasma Surgery SystemOS-CP 05-07HOS-CP 05-07H2016-07-18
M397HO280Holster OptionHO-28HO-282018-10-01
M397LSCP05280PlasmaJet Neutral Plasma Surgery SystemLS-CP-05-28LS-CP-05-282018-10-01
M397OSCG05120PlasmaJet Neutral Plasma Surgery SystemOS-CG-05-12OS-CG-05-122018-10-01
M397OSCP05070PlasmaJet Neutral Plasma Surgery SystemOS-CP-05-07OS-CP-05-072018-10-01
M397OSCP05120PlasmaJet Neutral Plasma Surgery SystemOS-CP-05-12OS-CP-05-122018-10-01
M397ARC1070ARIONARC-107ARC-1072026-04-28
M397ARCDK170ARIONARC-DK1-7ARC-DK1-72026-04-28
M397ARCSK170ARIONARC-SK1-7ARC-SK1-72026-04-28
M397PS102130AE0PlasmaJet Neutral Plasma Surgery SystemPS10-2130-AEPS10-2130-AE2018-10-01
M397PS102130AU0PlasmaJet Neutral Plasma Surgery SystemPS10-2130-AUPS10-2130-AU2018-10-01
M397PS102130BE0PlasmaJet Neutral Plasma Surgery SystemPS10-2130-BEPS10-2130-BE2018-10-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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