# K192970: Slimus

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Dec 1, 2020 after 405 days
- Product code: PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use)
- 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: 23 generations back to K943450 (1995). 186 ancestors in all.
No later device cites it as a predicate yet.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171111: Sculpsure, Cynosure, Inc. (2017) Summary page 4.

## Indications for use
The SLIMUS is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs. Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.

Source page: https://510kreport.com/device/K192970
Methodology: https://510kreport.com/methodology