# K111784: Venus Swan System

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept, Ltd.
- Decided: Oct 7, 2011 after 108 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: 16 generations back to K943450 (1995). 89 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100586: Venus Freeze System, Venus Concept, Ltd. (2010) Summary page 1.

## Most influential descendants
- K140629: Venus Swan (MP)2 (2014), 0 descendants of its own

## Indications for use
The Venus SwanTM is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrlinkles and rhytides.

Source page: https://510kreport.com/device/K111784
Methodology: https://510kreport.com/methodology