# K141063: Linscan 808, Linscan 980

- Pathway: 510(k) (Traditional)
- Applicant: Gme (German Medical Engineering) GmbH
- Decided: Jul 15, 2014 after 82 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: 16 generations back to K943450 (1995). 223 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090762: LEDA, Quantel Derma GmbH (2009) Summary page 2.

## Most influential descendants
- K213105: Epilaser Absolute (2022), 1 descendant of its own
- K180518: GME LinScan Lite 808 Laser System (2018), 1 descendant of its own
- K233224: Epilaser Pro (2024), 0 descendants of its own
- K192269: TwinScan 808/755 Laser System (2019), 0 descendants of its own
- K191611: Diode Laser Therapy Systems (2019), 0 descendants of its own

## Indications for use
The OMVE LinScan System with the applicators LinScan 808 and LinScan 980 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/K141063
Methodology: https://510kreport.com/methodology