Plasma Concepts
Country not established
- Devices
- 1
What Plasma Concepts makes
Plasma Concepts manufactures plasma-based medical devices, including the Plasma Pen (Plasma MD) and Plasma Pen (Plasma +), designed for precise tissue treatment and ablation procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) Ref K223440
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Plasma Concepts have in the registry?
The registry currently lists 1 device for Plasma Concepts. Devices recorded under merged duplicate company entries are counted once.
Which registries list Plasma Concepts's devices?
Among its 1 most recently registered device, Plasma Concepts has devices listed in FDA 510(k) (1 device).
What risk classes do Plasma Concepts's devices fall under?
Among its 1 most recently registered device, the classes recorded for Plasma Concepts's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Plasma Concepts in the registry?
The most recently registered devices listed for Plasma Concepts include Plasma Pen (Plasma MD); Plasma Pen (Plasma +).