# K063235: Cytori Lipoplasty System with Celase Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Cytori Therapeutics, Inc.
- Decided: Jan 24, 2007 after 91 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042261: Macropore Puricel Lipoplasty System, Macropore Biosurgery, Inc. (2004) Summary page 7.
- K771955: Trypsin 1%, Flow Laboratories, Inc. (1977) Summary page 7.
- K802493: Sputasol, Oxoid U.S.A., Inc. (1980) Summary page 7.

## Indications for use
The Cytori Lipoplasty System is intended 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 The Cytori Lipoplasty System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired. The Celase Reagent is intended for use in the fragmentation, emulsification, disaggregation, and liquefaction of soft tissues and subcutaneous fatty tissues within the Lipoplasty System's collection canister.

Source page: https://510kreport.com/device/K063235
Methodology: https://510kreport.com/methodology