# K090754: Lipocontrol

- Pathway: 510(k) (Traditional)
- Applicant: Osyris Medical
- Decided: Jan 21, 2011 after 672 days
- Product code: ORK (Laser Assisted Lipolysis)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010329 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073617: Pharaon Lipo, Osyris (2008) Summary page 1.
- K083379: Cynosure Smartlipo MPX Laser with Smartsense C Module, Cynosure, Inc. (2008) Summary page 1.
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 1.
- K022354: Ultraguide CTG 2000SA, Ultraguide, Ltd. (2002) Summary page 1.

## Indications for use
LIPOCONTROL is indicated for: Laser assisted lipolysis

Source page: https://510kreport.com/device/K090754
Methodology: https://510kreport.com/methodology