510(k) Report

FDA applicant

Moria SA

Antony, FR9 decisions1998–20170 recalls

FDA records 9 decisions for Moria SA (Antony, FR) from 1998 to 2017: 9 510(k) clearances. Most are in product codes HMY (Keratome, Battery-Powered) and HNO (Keratome, Ac-Powered). Its devices cite 16 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Moria, Inc.”.

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 Moria SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Moria SA 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?

  • HMYKeratome, Battery-Powered5decisions
  • HNOKeratome, Ac-Powered4decisions

Whose devices does it build on?

Its devices cite 16 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 7 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.

  • K002191Carriazo Barraquer II MicrokeratomeMoria, Inc. · 20007cite it
  • K981741Carriazo Barraquer MicrokeratomeMoria, Inc. · 19983cite it
  • K003594Carriazo Barraquer Single Use MicrokeratomeMoria, Inc. · 20011cites it
  • K043183EPI-KMoria SA · 20051cites it
  • K981742One UP Disposable Keratome HeadMoria, Inc. · 19981cites it
  • K040297Oneuse- Plus MicrokeratomeMoria SA · 20041cites it

What has FDA decided for it lately?

  • K172994EPI K ConsoleMoria SA · 2017
  • K043183EPI-KMoria SA · 2005
  • K032836M3 MicrokeratomeMoria SA · 2004
  • K040297Oneuse- Plus MicrokeratomeMoria SA · 2004
  • K022560M2 Single Use MicrokertomeMoria SA · 2002
  • K003594Carriazo Barraquer Single Use MicrokeratomeMoria, Inc. · 2001
  • K002191Carriazo Barraquer II MicrokeratomeMoria, Inc. · 2000
  • K981742One UP Disposable Keratome HeadMoria, Inc. · 1998

All 5 as Moria SA →All 4 as Moria, Inc. →