# K230659: Zionic Aesthetic

- Pathway: 510(k) (Traditional)
- Applicant: Termosalud
- Decided: Jun 8, 2023 after 91 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: 4 generations back to K122389 (2012). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200359: NuEra Tight, NuEra Tight EMS, Bios S.R.L. (2020) Summary page 4.

## Indications for use
The Zionic Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K230659
Methodology: https://510kreport.com/methodology