510(k) Report

FDA applicant

Optomedical Technologies GmbH

Luebeck, DE2 decisions2015–20202 recalls

FDA records 2 decisions for Optomedical Technologies GmbH (Luebeck, DE) from 2015 to 2020: 2 510(k) clearances. Most are in product codes OBO (Tomography, Optical Coherence) and HLI (Ophthalmoscope, Ac-Powered). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 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, ophthalmic panel, where it files most

How often FDA has decided Optomedical Technologies GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 12020: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2021

2021: 2
2015high 2 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Optomedical Technologies GmbH by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OBOTomography, Optical Coherence1decision
  • HLIOphthalmoscope, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142953OCT-CameraOptomedical Technologies GmbH · 20151cites it

What has FDA decided for it lately?

  • K200516OCT-Camera ID 21101A3Optomedical Technologies GmbH · 2020
  • K142953OCT-CameraOptomedical Technologies GmbH · 20152 recalls

All 2 as Optomedical Technologies GmbH →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K142953OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4Nov 3, 2021Class II
  • K142953OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4Nov 3, 2021Class II