← Back to catalogue

PlasmaJet Neutral Plasma Surgery System

FDA UDI

Class II (US FDA UDI)

by Plasma Surgical, Ltd.

Identity

Trade Name
PlasmaJet Neutral Plasma Surgery System FDA UDI
Generic Name
Plasma surgical system FDA UDI
Device Name
PlasmaJet V3 Plus Console System (Poland) FDA UDI
Model / Reference
PS10-2130-PL FDA UDI
Description
PlasmaJet V3 Plus Console System (Poland) FDA UDI

Identifiers

Catalog Number
PS10-2130-PL FDA UDI
Primary DI / UDI-DI
M397PS102130PL0 FDA UDI
510(k) Number
K121977 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Plasma surgical system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Plasma surgical system

PlasmaJet Neutral Plasma Surgery System by Plasma Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plasma surgical system.

Cleared under the same submission

K121977 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Plasma Surgical, Ltd.

Sources (1)

  • FDA UDI e266279a-1e7d-43aa-8be3-b1c4935b4e13 36 fields · synced Jun 1, 2026