# K101366: I-Lipo, Models A00-1238 (230V), A00-1239 (120V)

- Pathway: 510(k) (Traditional)
- Applicant: Chromogenex Technologies, Ltd.
- Decided: Sep 17, 2010 after 123 days
- Product code: NUV (Massager, Vacuum, Light Induced Heating)
- 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: 14 generations back to K943450 (1995). 59 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061603: Smoothshapes, Biocellulase, Inc. (2006) Summary page 1.
- K081962: Lapex BCS, Meridian Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K111501: I-Lipo System (2012), 15 descendants of its own
- 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

## Indications for use
The i~lipoTM Ultra - Vacuum Massage System - is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The i~lipoTM Ultra -Treatment Pads and Probes - are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.

Source page: https://510kreport.com/device/K101366
Methodology: https://510kreport.com/methodology