# K191065: Venus VivaTM

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept USA, Inc.
- Decided: Apr 1, 2020 after 345 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: 18 generations back to K943450 (1995). 258 ancestors in all.
No later device cites it as a predicate yet.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150161: Venus Viva SR Device, Venus Concept, Ltd. (2015) Summary page 4.
- K142910: Legacy BX, Venus Concept USA, Inc. (2014) Summary page 4.

## Indications for use
The Venus Viva™ Device is a non-invasive device intended to be used by aesthetic physicians or dermatologists. When used with the Diamondpolar applicator, the Venus Viva™ Device is intended for use in dermatological and surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV. When used with the Viva applicator, the Venus Viva™ Device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K191065
Methodology: https://510kreport.com/methodology