510(k) Report

FDA applicant

Vision Health Technology

Walker, MI3 decisions1984–19840 recalls

FDA records 3 decisions for Vision Health Technology (Walker, MI) in 1984: 3 510(k) clearances. Most are in product codes HME (Chair, Ophthalmic, Ac-Powered) and HLX (Photostimulator, 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 Vision Health Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vision Health Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vision Health Technology 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?

  • HMEChair, Ophthalmic, Ac-Powered1decision
  • HLXPhotostimulator, Ac-Powered1decision
  • HMDChair, Ophthalmic, Manual1decision

What has FDA decided for it lately?

  • K833446Downing Spectral IlluminatorVision Health Technology · 1984
  • K833539Dowing Ophthalmic Chair AC-PoweredVision Health Technology · 1984
  • K833538Dowing Ophthalmic Chair-Non/AC PowerVision Health Technology · 1984

All 3 as Vision Health Technology →