# K150161: Venus Viva SR Device

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept, Ltd.
- Decided: May 12, 2015 after 109 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: 17 generations back to K943450 (1995). 225 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102461: Fractora, Invasix, Ltd. (2011) Summary page 4.

## Most influential descendants
- K201164: Venus Viva MD Device (2020), 3 descendants of its own
- K212107: Reverso (2021), 1 descendant of its own
- K202988: Tixel System (2021), 1 descendant of its own
- K153717: Venus Versa System (2016), 1 descendant of its own
- K243139: Reverso Pro System (2025), 0 descendants of its own

## Indications for use
The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K150161
Methodology: https://510kreport.com/methodology