# K140629: Venus Swan (MP)2

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept, Ltd.
- Decided: Jun 25, 2014 after 106 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). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111670: Venus Freeze (MP)2 System, Venus Concept, Ltd. (2012) Summary page 2.
- K111784: Venus Swan System, Venus Concept, Ltd. (2011) Summary page 2.

## Indications for use
The Venus Swan (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K140629
Methodology: https://510kreport.com/methodology