510(k) Report

FDA applicant

Hai Laboratories, Inc.

Sound Beach, NY1 decision2000–20000 recalls

FDA records 1 decision for Hai Laboratories, Inc. (Sound Beach, NY) in 2000: 1 510(k) clearance. All are in product code HLI (Ophthalmoscope, Ac-Powered). 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 Hai Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hai Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hai Laboratories, 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?

  • HLIOphthalmoscope, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K994340Clinical Specular Microscope, Model Hai CL-1000XYZHai Laboratories, Inc. · 20001cites it

What has FDA decided for it lately?

  • K994340Clinical Specular Microscope, Model Hai CL-1000XYZHai Laboratories, Inc. · 2000

The one decision as Hai Laboratories, Inc. →