# K170738: InMode Diolaze XL

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Aug 7, 2017 after 150 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: 2 generations back to K053628 (2006). 2 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151947: LightSheer Desire Light Laser System, Lumenis, Ltd. (2015) Summary page 4.

## Most influential descendants
- K180719: InMode Diolaze System (2018), 13 descendants of its own
- K191321: Primelase Excellence (2019), 8 descendants of its own
- K193367: elysion-pro (2020), 3 descendants of its own
- K173677: InMode VLaze (2018), 3 descendants of its own
- K221571: InMode Multi-system (2022), 2 descendants of its own

## Indications for use
The InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as stable, long-term reduction in hair counts at 6,9 or 12 months following a treatment regime.

Source page: https://510kreport.com/device/K170738
Methodology: https://510kreport.com/methodology