# K004005: Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis System (Proposed)

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Oct 12, 2001 after 290 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910696 (1991). 3 ancestors in all.
49 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970471: Mentor Ultrasound Assisted Tissue Removal System (TRS), Mentor Corp. (1997) Summary page 5.

## Most influential descendants
- K022051: Soundvaser System (2002), 48 descendants of its own
- K042261: Macropore Puricel Lipoplasty System (2004), 36 descendants of its own
- K072587: Cytori Aft System (2007), 34 descendants of its own
- K092482: Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 (2009), 17 descendants of its own
- K081848: Lipose Fat Transfer System (2008), 12 descendants of its own

## Indications for use
The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

Source page: https://510kreport.com/device/K004005
Methodology: https://510kreport.com/methodology