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Sign in to claim this brandPlasma Surgical, Ltd.
United States·US-MF-000008505
Last updated May 23, 2026
What Plasma Surgical, Ltd. makes
Plasma Surgical, Ltd. manufactures plasma surgical systems and their associated handpieces, including the PlasmaJet Neutral Plasma Surgery System. These devices use neutral plasma technology for surgical applications, designed for precision cutting and coagulation in operating environments.
The company’s plasma surgical systems are classified as Class II devices under FDA regulations. They are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Plasma Surgical, Ltd. manufacture?
Plasma Surgical, Ltd. specializes in plasma surgical systems and their associated handpieces. Their primary product line includes devices like the PlasmaJet Neutral Plasma Surgery System, which utilize neutral plasma technology for surgical procedures. These systems are designed for precise cutting and coagulation in clinical settings.
Where is Plasma Surgical, Ltd. based?
Plasma Surgical, Ltd. is headquartered in the United States. The company’s location in the US may influence its regulatory compliance and market focus, particularly for devices authorized in North America.
Which regulatory registries list Plasma Surgical, Ltd.’s devices?
Plasma Surgical, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identification (UDI) system. These registries track devices that have undergone the required authorization processes under FDA regulations.
How are Plasma Surgical, Ltd.’s devices classified under FDA regulations?
Plasma Surgical, Ltd.’s devices, such as their plasma surgical systems, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1125, Northmeadow Parkway, Roswell, United States
- Website
- www.plasmasurgical.com
- —
- —
- [email protected]
- Phone
- +1 678 578-4390
- PRRC Contact
- Victor Stevens
- EUDAMED SRN
- US-MF-000008505
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (152)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Plasmajet Neutral Plasma Surgery System | K121977 | FDA 510(k) | Class II | Active |
| Plasmajet Neutral Plasma Surgery System | K080197 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Plasma Surgical, Ltd. has one FDA recall record initiated on 2012-04-27, which is listed with a terminated status. The recall was due to a potential failure in the glued seal between the stem and tip of the handpiece, which could result in a very small drop of distilled water coolant leakage during use.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 27, 2012 | Z-1794-2012 | — | terminated | Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use. |