# K991791: Sound Vaser System

- Pathway: 510(k) (Traditional)
- Applicant: Sound Surgical Technologies, LLC
- Decided: Aug 12, 1999 after 79 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- 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: 2 generations back to K884413 (1988). 5 ancestors in all.
49 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981262: Cusa Excel Ultrasonic Surgical Aspirator System, Valleylab, Inc. (1998) Summary page 2.
- K921251: Cusa System 200C and 200T Ultrasonic Aspirator, Valleylab, Inc. (1992) 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

## 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

Source page: https://510kreport.com/device/K991791
Methodology: https://510kreport.com/methodology