# K142952: InMode Diolaze Device

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Jan 13, 2015 after 95 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: 17 generations back to K943450 (1995). 224 ancestors in all.
No later device cites it as a predicate yet.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123682: Inmode Hair Removal (HR) Device, Inmode MD, Ltd. (2013) Summary page 4.
- K090762: LEDA, Quantel Derma GmbH (2009) Summary page 4.

## Indications for use
The InMode Diolaze device is indicated for use for hair removal and for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime

Source page: https://510kreport.com/device/K142952
Methodology: https://510kreport.com/methodology