510(k) Report

FDA applicant

Starmedtec GmbH

Starnberg, DE3 decisions2011–201314 recalls

FDA records 3 decisions for Starmedtec GmbH (Starnberg, DE) from 2011 to 2013: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 3 predicates, 1 of them its own earlier devices. 14 recalls are linked to its devices.

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 Starmedtec GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 22013: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

9in 2019

2014: 32017: 22019: 9
2011high 9 (2019) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Starmedtec GmbH by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K103654Vela XLStarmedtec GmbH · 20112cite it
  • K111475Auriga XLStarmedtec GmbH · 20112cite it
  • K121570Auriga QIStarmedtec GmbH · 20131cites it

What has FDA decided for it lately?

  • K121570Auriga QIStarmedtec GmbH · 2013
  • K111475Auriga XLStarmedtec GmbH · 201114 recalls
  • K103654Vela XLStarmedtec GmbH · 2011

All 3 as Starmedtec GmbH →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K111475AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007…Apr 8, 2019Class II
  • K111475AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System…Apr 8, 2019Class II
  • K111475AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL…Apr 8, 2019Class II
  • K111475AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System…Apr 8, 2019Class II
  • K111475AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser…Apr 8, 2019Class II
  • K111475AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007…Apr 8, 2019Class II