# K983065: Mentor Ultrasound-Assisted Tissue Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Dec 1, 1998 after 90 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- 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). 4 ancestors in all.
49 later devices descend from it; 1 cites it directly.
0 of 54 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 1.
- K971609: Sculpture, Servizi Medico Estetici Italinai Srl. (1997) Summary page 2.

## 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 Ultrasound-Assisted Tissue Removal System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.

Source page: https://510kreport.com/device/K983065
Methodology: https://510kreport.com/methodology