# K993868: The Soundvaser Dissection System

- Pathway: 510(k) (Traditional)
- Applicant: Sound Surgical Technologies, LLC
- Decided: Dec 21, 1999 after 36 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 K952726 (1995). 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)
- K990430: Ultracision Harmonic Scalpel Hand Piece, Ethicon Endo-Surgery, Inc. (1999) Summary page 2.
- K983316: Ultracision 5MM Instruments, Ethicon Endo-Surgery, Inc. (1998) Summary page 2.
- K971302: Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 Blade, Ethicon Endo-Surgery, Inc. (1997) Summary page 2.
- K962584: Ultracision 5MM Hard Sheath Laparosonic Blade, Ethicon Endo-Surgery, Inc. (1996) 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 Dissection System (Dissection Tips and Handpiece for The SoundVASER System) is indicated for use in when cutting and coagulation of soft tissues is desired, including bleeding control with minimal thermal injury.

Source page: https://510kreport.com/device/K993868
Methodology: https://510kreport.com/methodology