# K261562: Diode Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Sanhe LEFIS Electronics Co., Ltd.
- Decided: Sep 10, 2026 after 122 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 525 ancestors in all.
No later device cites it as a predicate yet.
0 of 526 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180719: InMode Diolaze System, Inmode MD, Ltd. (2018) Summary page 6.

## Indications for use
The Diode Laser Therapy System is intended for hair removal.

Source page: https://510kreport.com/device/K261562
Methodology: https://510kreport.com/methodology