# K243139: Reverso Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Indiba S. A. U.
- Decided: Jan 22, 2025 after 114 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: 22 generations back to K943450 (1995). 358 ancestors in all.
No later device cites it as a predicate yet.
0 of 359 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212107: Reverso, Intelis Instruments, Ltd. (2021) Summary page 5.
- K201164: Venus Viva MD Device, Venus Concept USA, Inc. (2020) Summary page 5.
- K172302: InMode PLUS System, Inmode MD, Ltd. (2017) Summary page 5.

## Indications for use
The Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. • The Reverso Pro System utilizing the Reverso Applicator is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin. • The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K243139
Methodology: https://510kreport.com/methodology