# K110306: Sound Surgical Vaser 2.1 Lipo System

- Pathway: 510(k) (Traditional)
- Applicant: Sound Surgical Technologies, LLC
- Decided: Jun 23, 2011 after 141 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910696 (1991). 19 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022051: Soundvaser System, Sound Surgical Technologies, LLC (2002) Summary page 5.

## Most influential descendants
- K190551: VASERlipo System (2019), 2 descendants of its own
- K244050: AYON Body Contouring System (AYON SYSTEM) (2025), 1 descendant of its own
- K212969: Liposaver (2024), 1 descendant of its own
- K254135: LipoSurg ARTIST (2026), 0 descendants of its own
- K252495: Lssa (NP-200) (2026), 0 descendants of its own

## Recalls of this device
- Jun 1, 2017 · Class II · Z-3047-2017: Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.

## Indications for use
The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with the Sound Surgical VASER 2.1 or as a stand-alone system. The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. The Sound Surgical VASER 2.1 Lipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues: Nuerosurgery; Gastrointestinal and affiliated organ surgery; Urological surgery; Plastic and reconstructive surgery; General surgery Gynecological surgery: Thoracic surgery; and Laparoscopic surgery.

Source page: https://510kreport.com/device/K110306
Methodology: https://510kreport.com/methodology