# K111670: Venus Freeze (MP)2 System

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept, Ltd.
- Decided: Mar 2, 2012 after 261 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.
13 later devices descend from it; 2 cite it directly.
0 of 103 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 2.

## Most influential descendants
- K142910: Legacy BX (2014), 11 descendants of its own
- K201164: Venus Viva MD Device (2020), 3 descendants of its own
- K191528: Venus Legacy Pro Device (2019), 3 descendants of its own
- K220592: Venus BlissMAX (2022), 1 descendant of its own
- K212107: Reverso (2021), 1 descendant of its own

## Indications for use
The Venus Freeze (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/K111670
Methodology: https://510kreport.com/methodology