# K201475: Ultimate Contour, Ultimate Contour Mini

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Oct 28, 2020 after 147 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171052: Ultimate Contour, Ultimate Contour Mini, CAO Group, Inc. (2017) Summary page 4.
- K141708: Ultrashape System, Syneron Medical, Ltd. (2014) Summary page 4.

## Indications for use
1) Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. 2) Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.

Source page: https://510kreport.com/device/K201475
Methodology: https://510kreport.com/methodology