510(k) Report

FDA applicant

Us Ophthalmic, LLC

Miami, FL2 decisions2006–20080 recalls

FDA records 2 decisions for Us Ophthalmic, LLC (Miami, FL) from 2006 to 2008: 2 510(k) clearances. All are in product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). Its devices cite 2 predicates, 0 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 Us Ophthalmic, LLC’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 — Us Ophthalmic, LLC 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?

  • HJOBiomicroscope, Slit-Lamp, Ac-Powered2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K080776Gilras Slit Lamp, Models GR-SL7, GR-SL36, GR-SL54 and GR-SL72Us Ophthalmic, LLC · 2008
  • K063416Luxvision Slit LampUs Ophthalmic, LLC · 2006

All 2 as Us Ophthalmic, LLC →