510(k) Report

FDA applicant

Med-Logics, Inc.

Laguna Hills, CA12 decisions1996–20041 recall

FDA records 12 decisions for Med-Logics, Inc. (Laguna Hills, CA) from 1996 to 2004: 12 510(k) clearances. Most are in product codes HNO (Keratome, Ac-Powered) and KYG (Device, Irrigation, Ocular Surgery). 1 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 Med-Logics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med-Logics, Inc. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Med-Logics, Inc. 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-Powered7decisions
  • KYGDevice, Irrigation, Ocular Surgery2decisions
  • MSRTubing, Replacement, Phacofragmentation Unit2decisions
  • HOZSponge, Ophthalmic1decision

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.

  • K962661ML Microkeratome BladeMed-Logics, Inc. · 19963cite it
  • K002279ML Eye Spear, Model ML 27 ESMed-Logics, Inc. · 20001cites it
  • K022982Med-Logics Microkeratome Blade, Model 7050CLBMed-Logics, Inc. · 20021cites it

What has FDA decided for it lately?

  • K033293Med-Logics, Model ML7090Med-Logics, Inc. · 20041 recall
  • K022982Med-Logics Microkeratome Blade, Model 7050CLBMed-Logics, Inc. · 2002
  • K022716Med-Logics Microkeratome Blade, Model 7020CLBMed-Logics, Inc. · 2002
  • K010872ML Blade, Model ML7030Med-Logics, Inc. · 2001
  • K010353Med-Logics Disposable Alk TubingMed-Logics, Inc. · 2001
  • K002515Medlogics ML 4000, Model 4000Med-Logics, Inc. · 2001
  • K002279ML Eye Spear, Model ML 27 ESMed-Logics, Inc. · 2000
  • K983448ML Universal TubingMed-Logics, Inc. · 1998

All 12 as Med-Logics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K033293ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated…Jan 13, 2015Class II