# K022051: Soundvaser System

- Pathway: 510(k) (Traditional)
- Applicant: Sound Surgical Technologies, LLC
- Decided: Sep 11, 2002 after 79 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910696 (1991). 18 ancestors in all.
48 later devices descend from it; 4 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991791: Sound Vaser System, Sound Surgical Technologies, LLC (1999) Summary page 6.
- K993868: The Soundvaser Dissection System, Sound Surgical Technologies, LLC (1999) Summary page 6.
- K970471: Mentor Ultrasound Assisted Tissue Removal System (TRS), Mentor Corp. (1997) Summary page 6.
- K983065: Mentor Ultrasound-Assisted Tissue Removal System, Mentor Corp. (1998) Summary page 6.
- K004005: Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis System (Proposed), Mentor Corp. (2001)

## Most influential descendants
- 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
- K120902: GID 700 (2012), 11 descendants of its own

## Recalls of this device
- Dec 21, 2010 · Not classified · Z-0939-2011: Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
- Dec 28, 2007 · Not classified · Z-0933-2008: Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.

## Indications for use
The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Source page: https://510kreport.com/device/K022051
Methodology: https://510kreport.com/methodology