FDA.reportPublic FDA data

ARION

Primary DI
M397ARCDK170
Brand
ARION
Company
PLASMA SURGICAL, INC
Model
ARC-DK1-7
Catalog number
ARC-DK1-7
Device description
ARC Handpiece Drape Kit 7cm
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
M397ARCDK179PackageHIBCC15In Commercial Distribution
M397ARCDK170PrimaryHIBCC0
00850007717018SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007717018008500077170188500077170180850007717018

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.

Contacts#

Phone, Email table
PhoneEmail
6785784390cs@plasmasurgical.com

Regulatory Flags#

DUNS number
360799048
Device count
1
Lot or batch
true
Expiration 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
M397PS104130ARIONPS10-4130PS10-41302026-05-06
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16