# K242553: MIRARI® Cold Plasma System ( GV-M2-01)

- Pathway: 510(k) (Traditional)
- Applicant: General Vibronics, Inc.
- Decided: Nov 21, 2024 after 86 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- 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: 23 generations back to K943450 (1995). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200241: TempSure System, Cynosure, LLC (2020) Summary page 5.

## Indications for use
MIRARI® Cold Plasma System provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation.

Source page: https://510kreport.com/device/K242553
Methodology: https://510kreport.com/methodology