510(k) Report

FDA applicant

G. Rodenstock Instrumente GmbH

Munchen 70, West Germany, DE3 decisions1986–19970 recalls

FDA records 3 decisions for G. Rodenstock Instrumente GmbH (Munchen 70, West Germany, DE) from 1986 to 1997: 3 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and HLI (Ophthalmoscope, Ac-Powered). No recall is linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided G. Rodenstock Instrumente GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for G. Rodenstock Instrumente GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — G. Rodenstock Instrumente GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQFLaser, Ophthalmic2decisions
  • HLIOphthalmoscope, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K871268Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 19874cite it
  • K973220Rodenstock Laser SlitlampG. Rodenstock Instrumente GmbH · 19971cites it

What has FDA decided for it lately?

  • K973220Rodenstock Laser SlitlampG. Rodenstock Instrumente GmbH · 1997
  • K871268Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
  • K864063Orion 3001, Laser PhotocoagulatorG. Rodenstock Instrumente GmbH · 1986

All 3 as G. Rodenstock Instrumente GmbH →