# K212107: Reverso

- Pathway: 510(k) (Traditional)
- Applicant: Intelis Instruments, Ltd.
- Decided: Nov 10, 2021 after 127 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: 19 generations back to K943450 (1995). 259 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201164: Venus Viva MD Device, Venus Concept USA, Inc. (2020) Summary page 4.

## Most influential descendants
- K243139: Reverso Pro System (2025), 0 descendants of its own

## Indications for use
The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K212107
Methodology: https://510kreport.com/methodology