510(k) Report

FDA applicant

Schwind Eye-Tech-Solutions GmbH & Co. KG

Coto De Caza, CA2 decisions2004–20080 recalls

FDA records 2 decisions for Schwind Eye-Tech-Solutions GmbH & Co. KG (Coto De Caza, CA) from 2004 to 2008: 2 510(k) clearances. All are in product code HNO (Keratome, Ac-Powered). Its devices cite 9 predicates, 1 of them its own earlier devices. 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 Schwind Eye-Tech-Solutions GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Schwind Eye-Tech-Solutions GmbH & Co. KG 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?

  • HNOKeratome, Ac-Powered2decisions

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 20043cite it

What has FDA decided for it lately?

  • K082043Carriazo-Pendular MicrokeratomeSchwind Eye-Tech-Solutions GmbH & Co. KG · 2008
  • K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004

All 2 as Schwind Eye-Tech-Solutions GmbH & Co. KG →