# K202106: Plasmage System

- Pathway: 510(k) (Traditional)
- Applicant: Brera Medical, Inc.
- Decided: Apr 6, 2022 after 616 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 6 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)
- K161134: Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator, Bovie Medical Corporation (2016) Summary page 4.
- K103654: Vela XL, Starmedtec GmbH (2011) Summary page 4.

## Indications for use
Removal and destruction of skin lesions and the coagulation of skin tissue.

Source page: https://510kreport.com/device/K202106
Methodology: https://510kreport.com/methodology