# K190551: VASERlipo System

- Pathway: 510(k) (Special)
- Applicant: Solta Medical
- Decided: May 1, 2019 after 57 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910696 (1991). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110306: Sound Surgical Vaser 2.1 Lipo System, Sound Surgical Technologies, LLC (2011) Summary page 5.

## Most influential descendants
- K212969: Liposaver (2024), 1 descendant of its own
- K252495: Lssa (NP-200) (2026), 0 descendants of its own

## Indications for use
The VASERIlipo System is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. The VentX console is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERIlipo System or as a stand-alone system. The VASERlIipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. The VASERIipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues: * Neurosurgery « Gastrointestinal and affiliated organ surgery « Urological surgery « Plastic and reconstructive surgery * General surgery * Orthopedic surgery * Gynecological surgery * Thoracic surgery and « Laparoscopic surgery

Source page: https://510kreport.com/device/K190551
Methodology: https://510kreport.com/methodology