# K192275: invisa-RED ELITE

- Pathway: 510(k) (Traditional)
- Applicant: IR Technology, LLC
- Decided: Aug 19, 2020 after 363 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). 114 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 116 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.
- K123237: Zerona 2.0 Laser, Erchonia Corporation (2013) Summary page 5.
- K143741: Lipofina Laser System, Yolo Medical, Inc. (2015) Summary page 5.
- K160880: Photonica Professional, Ward Photonics, LLC (2016) Summary page 5.

## Most influential descendants
- K213534: PHantom Trilogy (2022), 0 descendants of its own

## Indications for use
The InvisaRED™ Technology ELITE is indicated for use as a non-invasive dermatological aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation, affecting adipocyte cells within the adipose layer for the release of lipids from these cells.

Source page: https://510kreport.com/device/K192275
Methodology: https://510kreport.com/methodology