# K100586: Venus Freeze System

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept, Ltd.
- Decided: Nov 29, 2010 after 272 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: 15 generations back to K943450 (1995). 88 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 2.
- K051214: Aluma Skin Renewal System, Lumenis, Inc. (2005) Summary page 2.
- K031671: Polaris WR, Syneron Medical, Ltd. (2003) Summary page 2.

## Most influential descendants
- K111026: Apollo (2011), 14 descendants of its own
- K111670: Venus Freeze (MP)2 System (2012), 13 descendants of its own
- K142910: Legacy BX (2014), 11 descendants of its own
- K140255: Stop U (Packed Black Usa); Stop U (Packed White Usa) (2014), 7 descendants of its own
- K182774: STOP U (Packed Black USA), STOP U (Packed White USA) (2019), 5 descendants of its own

## Indications for use
The Venus Freeze is a non-invasive device intended for use in Dennatologic and general surgical procedures for the non-invasive treatment of inild to moderate facial wrinkles and rhytides.

Source page: https://510kreport.com/device/K100586
Methodology: https://510kreport.com/methodology