# K230412: Symmed Elite Aesthetic

- Pathway: 510(k) (Traditional)
- Applicant: Termosalud
- Decided: Apr 13, 2023 after 57 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: 3 generations back to K122389 (2012). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161458: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care, Indiba USA, Inc. (2016) Summary page 4.

## Most influential descendants
- K243716: Zionic Pro Max  (Radiofrequency) (2025), 0 descendants of its own

## Indications for use
The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, 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/K230412
Methodology: https://510kreport.com/methodology