# K192269: TwinScan 808/755 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Gme German Medical Engineering GmbH
- Decided: Nov 19, 2019 after 90 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). 528 ancestors in all.
No later device cites it as a predicate yet.
0 of 529 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180518: GME LinScan Lite 808 Laser System, Gme German Medical Engineering GmbH (2018) Summary page 5.
- K143519: The MeDioStar NeXT Family, Asclepion Laser Technologies GmbH (2015) Summary page 5.

## Indications for use
The GME TwinScan 808/755 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. The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).

Source page: https://510kreport.com/device/K192269
Methodology: https://510kreport.com/methodology