# Gme German Medical Engineering GmbH

- Location (FDA's records): Nuremberg, DE
- FDA decisions: 6 (2014–2023): 6 510(k) clearances
- Names in FDA's records: Gme German Medical Engineering GmbH (4); Gme (German Medical Engineering) GmbH (2)
- Product codes: GEX (5), FTC (1)
- 510(k) review time since 2016: median 148 days, against 88 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Asclepion Laser Technologies GmbH: 2 (https://510kreport.com/company/asclepion-laser-technologies)
- Quantel Derma GmbH: 2 (https://510kreport.com/company/quantel-derma)
- Clarteis: 2 (https://510kreport.com/company/clarteis)
- Light Bioscience, LLC: 1 (https://510kreport.com/company/light-bioscience)
- Medmix Co., Ltd.: 1 (https://510kreport.com/company/medmix)
- Solta Medical, Inc.: 1 (https://510kreport.com/company/solta-medical)

## Firms that cite its devices most
- Clarteis: 1 (https://510kreport.com/company/clarteis)
- Wingderm Electro-Optics, Ltd.: 1 (https://510kreport.com/company/wingderm-electro-optics)
- Epilady 2000, LLC: 1 (https://510kreport.com/company/epilady-2000)
- Chongqing Peninsula Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/chongqing-peninsula-medical-technology)

## Its most-cited devices
- K141063: Linscan 808, Linscan 980 (2014), cited by 3
- K150752: GME ExSys 308 (2015), cited by 3
- K180518: GME LinScan Lite 808 Laser System (2018), cited by 1

## Recent decisions
- K221623: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm (Mar 10, 2023)
- K203054: FlexSys (Mar 5, 2021)
- K192269: TwinScan 808/755 Laser System (Nov 19, 2019)
- K180518: GME LinScan Lite 808 Laser System (Jul 23, 2018)
- K150752: GME ExSys 308 (Jul 31, 2015)
- K141063: Linscan 808, Linscan 980 (Jul 15, 2014)

Source page: https://510kreport.com/company/gme-german-medical-engineering