# K111501: I-Lipo System

- Pathway: 510(k) (Traditional)
- Applicant: Chromogenex Technologies Limited
- Decided: Mar 23, 2012 after 297 days
- Product code: OLI (Fat Reducing Low Level Laser)
- Device class: 2
- Regulation: 21 CFR 878.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 61 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101366: I-Lipo, Models A00-1238 (230V), A00-1239 (120V), Chromogenex Technologies, Ltd. (2010) Summary page 1.
- DEN090008: Erchonia ML Scanner (MLS), Erchonia Medical (2010). Our reading of the summary gave K082609, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090008, Erchonia ML Scanner (MLS) (Erchonia Medical), granted Aug 24, 2010; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K130341: Strawberry, Strawberry & Cream (2013), 12 descendants of its own
- K202955: Contour Light CL-100 (2021), 8 descendants of its own
- K232977: Biophotas Celluma CONTOUR (2023), 5 descendants of its own
- K143741: Lipofina Laser System (2015), 3 descendants of its own
- K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (2026), 1 descendant of its own

## Indications for use
The j~ljp0 TM Low Level Laser System is indicated for Non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

Source page: https://510kreport.com/device/K111501
Methodology: https://510kreport.com/methodology