FDA.reportPublic FDA data

PlasmaJet Neutral Plasma Surgery System

Primary DI
M397PS102130
Brand
PlasmaJet Neutral Plasma Surgery System
Company
PLASMA SURGICAL, INC
Model
PS10-2130
Catalog number
PS10-2130
Device description
PlasmaJet V3 Plus Console System
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K121977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121977000PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMPlasma Surgical Limited2012-11-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M397PS102130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Plasma surgical systemAn assembly of electrically-powered devices designed to generate a fine plasma jet used to coagulate, cut, and/or vaporize/ablate tissue and/or reduce inflammation/promote healing during open, laparoscopic or topical surgery. The system has a gas [e.g., argon (Ar)] supply or an ambient air input, and typically includes a control unit, a handpiece(s) with connection cable and foot-switch. The plasma [e.g., argon (Ar), nitric oxide] is generated in the handpiece and is applied to tissue where the surgical effect is achieved without passing electric current through the body.

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
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
M397ARCDK170ARIONARC-DK1-7ARC-DK1-72026-04-28
M397ARCSK170ARIONARC-SK1-7ARC-SK1-72026-04-28
M397S2CDU120PlasmaJet Neutral Plasma Surgery SystemS2-CDU-12S2-CDU-122023-09-07
M397S2CDU280PlasmaJet Neutral Plasma Surgery SystemS2-CDU-28S2-CDU-282023-09-07
M397S2CDU28H0PlasmaJet Neutral Plasma Surgery SystemS2-CDU-28HS2-CDU-28H2023-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07
08800017100920VIVACE Microneedle Cartridgeshenb Co., Ltd.GEI2026-08-07
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28