510(k) Report

FDA applicant

Gme German Medical Engineering GmbH

Nuremberg, DE6 decisions2014–20230 recalls

FDA records 6 decisions for Gme German Medical Engineering GmbH (Nuremberg, DE) from 2014 to 2023: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and FTC (Light, Ultraviolet, Dermatological). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Gme (German Medical Engineering) GmbH”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Gme German Medical Engineering GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014: 12015: 12018: 12019: 12021: 12023: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Gme German Medical Engineering GmbH by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gme German Medical Engineering GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument5decisions
  • FTCLight, Ultraviolet, Dermatological1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 148 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH · 20143cite it
  • K150752GME ExSys 308Gme (German Medical Engineering) GmbH · 20153cite it
  • K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH · 20181cites it

What has FDA decided for it lately?

  • K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH · 2023
  • K203054FlexSysGme German Medical Engineering GmbH · 2021
  • K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH · 2019
  • K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH · 2018
  • K150752GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
  • K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH · 2014

All 4 as Gme German Medical Engineering GmbH →All 2 as Gme (German Medical Engineering) GmbH →