# K231971: Deka Physiq 360

- Pathway: 510(k) (Traditional)
- Applicant: El.En S.P.A.
- Decided: Sep 26, 2023 after 85 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: 24 generations back to K943450 (1995). 187 ancestors in all.
No later device cites it as a predicate yet.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171992: SculpSure, Cynosure, Inc. (2017) Summary page 5.

## Indications for use
The DEKA PHYS IQ 360 is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs, in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

Source page: https://510kreport.com/device/K231971
Methodology: https://510kreport.com/methodology