# K223440: Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

- Pathway: 510(k) (Traditional)
- Applicant: Plasma Concepts
- Decided: Mar 2, 2023 after 108 days
- Product code: QVJ (Low Power Electrosurgical Devices For Skin Lesion Destruction)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933002 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201738: SubNovii Advanced Plasma Technology, Cartessa Aesthetics (2020) Summary page 4.

## Indications for use
The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.

Source page: https://510kreport.com/device/K223440
Methodology: https://510kreport.com/methodology