# K161458: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care

- Pathway: 510(k) (Traditional)
- Applicant: Indiba USA, Inc.
- Decided: Oct 3, 2016 after 130 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: 2 generations back to K122389 (2012). 3 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133739: Trusculpt, Cutera, Inc. (2014) Summary page 5.
- K132949: Pellefirm, Ellman International, Inc. (2014) Summary page 5.

## Most influential descendants
- K191202: Capenergy - C100, C200, C300, C400, C50 (2020), 4 descendants of its own
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (2023), 3 descendants of its own
- K241832: Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (2025), 1 descendant of its own
- K230412: Symmed Elite Aesthetic (2023), 1 descendant of its own
- K253480: Capenergy C Equipments RF C200 and C400 Drakarian (2026), 0 descendants of its own

## Indications for use
The Indiba Diathermia Radiofrequency Devices are 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/K161458
Methodology: https://510kreport.com/methodology