# K180518: GME LinScan Lite 808 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Gme German Medical Engineering GmbH
- Decided: Jul 23, 2018 after 146 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.
1 later device descends from it; 1 cites it directly.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141063: Linscan 808, Linscan 980, Gme (German Medical Engineering) GmbH (2014) Summary page 5.

## Most influential descendants
- K192269: TwinScan 808/755 Laser System (2019), 0 descendants of its own

## Indications for use
The GME LinScan Lite 808 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

Source page: https://510kreport.com/device/K180518
Methodology: https://510kreport.com/methodology