# K180719: InMode Diolaze System

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Jun 14, 2018 after 87 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: 21 generations back to K943450 (1995). 524 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 538 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143519: The MeDioStar NeXT Family, Asclepion Laser Technologies GmbH (2015) Summary page 4.
- K170738: InMode Diolaze XL, Inmode MD, Ltd. (2017) Summary page 4.
- K141555: Advantage, Lutronic Corporation (2014) Summary page 4.

## Most influential descendants
- K191321: Primelase Excellence (2019), 8 descendants of its own
- K193367: elysion-pro (2020), 3 descendants of its own
- K221571: InMode Multi-system (2022), 2 descendants of its own
- K201594: Primelase Excellence (2020), 2 descendants of its own
- K251632: Optimas MAX System (2025), 1 descendant of its own

## Indications for use
The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.

Source page: https://510kreport.com/device/K180719
Methodology: https://510kreport.com/methodology