# K041058: Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems

- Pathway: 510(k) (Traditional)
- Applicant: Misonix, Inc.
- Decided: May 17, 2004 after 24 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.
4 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004005: Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis System (Proposed), Mentor Corp. (2001) Summary page 5.
- K022051: Soundvaser System, Sound Surgical Technologies, LLC (2002) Summary page 5.

## Most influential descendants
- K052183: Soring GMBH Sonoca Lipo (2005), 3 descendants of its own
- K092066: Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste Collection Kit (Was-01), Phaser Cannulae (2010), 2 descendants of its own
- K121218: Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3 Aperture Reusable Cannula, 4MM Dia, (2012), 1 descendant of its own
- K130152: Hydrasolve Lipoplasty System (2013), 0 descendants of its own

## Recalls of this device
- Jul 27, 2007 · Not classified · Z-1230-2007: Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x

## Indications for use
LYSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

Source page: https://510kreport.com/device/K041058
Methodology: https://510kreport.com/methodology