Identity
- Trade Name
- Plasma IQ System FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of a targeted micro beam of plasma energy. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use. FDA UDI
- Model / Reference
- PLK-755 FDA UDI
- Description
- PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of a targeted micro beam of plasma energy. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use. FDA UDI
Identifiers
- Catalog Number
- 100-1200 FDA UDI
- Primary DI / UDI-DI
- 00850017374003 FDA UDI
- 510(k) Number
- K192813 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, single-use 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical handpiece, single-use
Plasma IQ System by Neauvia North America, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192813 also covers:
- Plasma IQ Docking Station — NEAUVIA NORTH AMERICA, INC
- Plasma IQ Electrode Curved (1 piece) — NEAUVIA NORTH AMERICA, INC
- Plasma IQ Electrode Curved (10 piece) — NEAUVIA NORTH AMERICA, INC
- Plasma IQ Electrode Straight (1 piece) — NEAUVIA NORTH AMERICA, INC
- Plasma IQ Electrode Straight (10 piece) — NEAUVIA NORTH AMERICA, INC
- Plasma IQ Handpiece — NEAUVIA NORTH AMERICA, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neauvia North America, Inc
Sources (1)
- FDA UDI 5ad1682f-2186-4a36-96c3-b2eed731580d 36 fields · synced May 31, 2026