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PlasmaJet Neutral Plasma Surgery System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K080197Ref S2-CDU-07Ref OS-CG-05-12HRef OS-CP-05-12HRef LS-CP-05-28HRef OS-CG-05-07HRef S2-CDU-28HRef OS-CG-05-07Ref LS-CG-05-28Ref PS10-2130Ref S2-CDU-07HRef S2-CDU-12Ref OS-CG-05-12

by Plasma Surgical, Ltd.

Identity

Trade Name
PlasmaJet Neutral Plasma Surgery System EUDAMEDFDA UDI
Generic Name
Plasma surgical system handpiece FDA UDI
Device Name
PlasmaJet Neutral Plasma Handpiece EUDAMED
PlasmaJet Neutral Plasma Handpiece with Holster EUDAMED
PlasmaJet Neutral Plasma Surgery System EUDAMED
PlasmaJet Neutral Plasma Handpiece w/Holster EUDAMED
Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System FDA UDI
Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System FDA UDI
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System FDA UDI
Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for PlamaJet System FDA UDI
Single-Use Cut\Coagulation Handpiece for Laparoscopic Surgical for the PlasmaJet System FDA UDI
Model / Reference
S2-CDU-12 EUDAMEDFDA UDI
OS-CG-05-07 EUDAMEDFDA UDI
OS-CG-05-12 EUDAMEDFDA UDI
LS-CG-05-28 EUDAMEDFDA UDI
S2-CDU-28H EUDAMEDFDA UDI
S2-CDU-07 EUDAMED
OS-CG-05-12H EUDAMED
OS-CP-05-12H EUDAMED
LS-CP-05-28H EUDAMED
OS-CG-05-07H EUDAMED
PS10-2130 EUDAMED
S2-CDU-07H EUDAMED
Description
Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System FDA UDI
Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System FDA UDI
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System FDA UDI
Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for PlamaJet System FDA UDI
Single-Use Cut\Coagulation Handpiece for Laparoscopic Surgical for the PlasmaJet System FDA UDI

Identifiers

Catalog Number
S2-CDU-12 FDA UDI
OS-CG-05-07 FDA UDI
OS-CG-05-12 FDA UDI
LS-CG-05-28 FDA UDI
S2-CDU-28H FDA UDI
Primary DI / UDI-DI
++M397S2CDU0703Q EUDAMED
++M397OSCG0512H0NZ EUDAMED
++M397OSCP0512H0TS EUDAMED
++M397LSCP0528H0S8 EUDAMED
++M397OSCG0507H0PK EUDAMED
++M397S2CDU28H0BE EUDAMED
++M397OSCG05070EA EUDAMED
++M397LSCG05280CJ EUDAMED
++M397PS102130VR EUDAMED
++M397S2CDU07H0AT EUDAMED
++M397S2CDU1203E EUDAMED
++M397OSCG05120DY EUDAMED
M397S2CDU120 FDA UDI
M397OSCG05070 FDA UDI
M397OSCG05120 FDA UDI
M397LSCG05280 FDA UDI
M397S2CDU28H0 FDA UDI
Basic UDI-DI
B-++M397S2CDU0703Q EUDAMED
B-++M397OSCG0512H0NZ EUDAMED
B-++M397OSCP0512H0TS EUDAMED
B-++M397LSCP0528H0S8 EUDAMED
B-++M397OSCG0507H0PK EUDAMED
B-++M397S2CDU28H0BE EUDAMED
B-++M397OSCG05070EA EUDAMED
B-++M397LSCG05280CJ EUDAMED
B-++M397PS102130VR EUDAMED
B-++M397S2CDU07H0AT EUDAMED
B-++M397S2CDU1203E EUDAMED
B-++M397OSCG05120DY EUDAMED
510(k) Number
K080197 FDA 510(k)
K121977 FDA UDI
FDA Product Code
GEI FDA 510(k)FDA UDI
EMDN Code
K020480 DEVICES FOR SURGERY WITH ARGON GAS GENERATOR, SINGLE-USE- ACCESSORIES EUDAMED
GMDN Term
Plasma surgical system handpiece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)FDA UDI
Market of Registration
France EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMED

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 12 Centimeter FDA UDI
Length — 7 Centimeter FDA UDI
Length — 28 Centimeter FDA UDI

The PlasmaJet Neutral Plasma Surgery System is a Neutral Plasma Surgical Device (Device Type: GEI—General and Plastic Surgery) designed for precise tissue ablation and coagulation. It employs plasma energy to cut, seal, and vaporise tissue with minimal thermal damage, reducing the need for traditional scalpel incisions or electrocautery. The system is particularly suited for soft tissue procedures in general and plastic surgery, offering controlled energy delivery for improved hemostasis and reduced collateral injury.

This device is supplied as a reusable system, requiring proper maintenance and sterilisation between uses in accordance with manufacturer guidelines. It is intended for use in clinical settings where MRI safety is not a concern, as it does not contain metallic components that could interfere with imaging. The system is authorised under FDA 510K clearance and MDD compliance, ensuring adherence to regulatory standards for surgical instruments. Storage and handling must follow sterile protocols to preserve functionality and patient safety.

Frequently asked questions

How is the PlasmaJet Neutral Plasma Surgery System different from traditional scalpel or electrocautery tools in terms of tissue handling?

The PlasmaJet system uses neutral plasma energy to cut, seal, and vaporize tissue with minimal thermal damage, reducing collateral injury compared to traditional scalpel incisions or electrocautery. This allows for more precise tissue ablation and improved hemostasis, particularly beneficial in soft tissue procedures like those in general and plastic surgery.

Is the PlasmaJet Neutral Plasma Surgery System reusable, and what maintenance is required between uses?

Yes, the PlasmaJet system is designed as a reusable device. Between uses, it must undergo proper maintenance and sterilization following the manufacturer’s guidelines to ensure functionality and patient safety. Sterile protocols must also be followed during storage and handling.

Can this device be used in a clinical setting where MRI scans are performed on patients afterward?

No, the PlasmaJet system is not MRI-compatible. Since it does not contain metallic components, it won’t interfere with imaging—but its design does not account for MRI safety protocols, so it should not be used in settings where patients will undergo MRI scans immediately afterward.

What regulatory pathways does the PlasmaJet Neutral Plasma Surgery System follow, and what does that mean for its use?

The device is authorized under FDA 510K clearance (K080197) and complies with the Medical Device Directive (MDD), confirming it meets regulatory standards for surgical instruments. This means it has undergone evaluation for safety and effectiveness, ensuring it can be used in clinical settings with confidence in its performance and compliance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Plasma Surgical, Ltd.

Sources (18)

  • FDA 510(k) K080197 24 fields · synced Sep 18, 2026
  • FDA UDI 94fc9cf4-41ba-40d3-923b-750d82034d6f 37 fields · synced May 29, 2026
  • FDA UDI 88dbdc21-6ee3-4fc9-a280-032a4396bd76 37 fields · synced May 29, 2026
  • FDA UDI a8ef7c09-2113-4948-8df2-6595bbce13c4 37 fields · synced May 30, 2026
  • FDA UDI 10ac4490-9650-475c-9bf4-76ef42194073 37 fields · synced May 30, 2026
  • FDA UDI 0dacc0ce-d091-4824-9f24-cbabf96c0eee 37 fields · synced May 30, 2026
  • EUDAMED 018c172a-d07e-4cc9-b9bf-bcbfcf339e58 61 fields · synced Jul 8, 2026
  • EUDAMED e918cc22-69d5-433d-b009-3a49ac01fbf8 61 fields · synced Jul 9, 2026
  • EUDAMED 64dcf3a2-05c1-439f-8d13-29d4e3fdb1f8 61 fields · synced Jul 10, 2026
  • EUDAMED c73bb0af-590b-4455-b86f-202a8b76f506 61 fields · synced Jul 13, 2026
  • EUDAMED 879471fc-6a23-4e5d-87d1-b24010b31132 61 fields · synced Jul 14, 2026
  • EUDAMED 6648352a-286d-47ce-8417-bfae7828667e 61 fields · synced Jul 18, 2026
  • EUDAMED 17194c0c-859a-42ca-932f-cc0436a674e8 61 fields · synced Jul 22, 2026
  • EUDAMED 2e900ead-fdd3-481a-905a-b9d2a3cca4e3 61 fields · synced Jul 23, 2026
  • EUDAMED 8b622c33-ed92-4cfe-999b-69c6e9ab6c1a 61 fields · synced Jul 23, 2026
  • EUDAMED 762cb4e9-288e-4fee-a0b0-61d7c1ce33ab 61 fields · synced Jul 24, 2026
  • EUDAMED 30e731f4-d04d-450f-82b9-b9de8d43fc84 61 fields · synced Jul 31, 2026
  • EUDAMED 1440d7f9-bf58-45af-b68c-efa31fa8c3bb 61 fields · synced Aug 3, 2026