TwinScan 808/755 Laser System— 510(k) K192269

Clearance details

Applicant

Gme German Medical Engineering GmbH

Product code

Code GEX

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2019-08-21

Decision date

2019-11-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Nuremberg, DE

• K261562 — Diode Laser Therapy System2026-09-10
• K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)2026-09-10
• K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)2026-09-02
• K262269 — CO2 Laser System (MBT- CO2 Laser)2026-09-01
• K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)2026-08-27

• K221623 — FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm2023-03-10
• K203054 — FlexSys2021-03-05
• K180518 — GME LinScan Lite 808 Laser System2018-07-23
• K150752 — GME ExSys 3082015-07-31
• K141063 — LINSCAN 808, LINSCAN 9802014-07-15

Death

33

Injury

3,045

Malfunction

12,903

Other

25

Total

16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →