# K134040: BTL-9000; BTL-9000 Radiofrequency Module

- Pathway: 510(k) (Traditional)
- Applicant: Btl Industries, Ltd.
- Decided: Sep 10, 2014 after 253 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: 17 generations back to K943450 (1995). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130341: Strawberry, Strawberry & Cream, Laser Lipo Limited (2013) Summary page 5.

## Indications for use
The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

Source page: https://510kreport.com/device/K134040
Methodology: https://510kreport.com/methodology