FDA applicant

Luneau Laboratories

Washington, DC5 decisions1984–19850 recalls

FDA records 5 decisions for Luneau Laboratories (Washington, DC) from 1984 to 1985: 5 510(k) clearances. Most are in product codes HMF (Stand, Instrument, Ac-Powered, Ophthalmic) and HMH (Rack, Skiascopic). 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 Luneau Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Luneau Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Luneau Laboratories by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Luneau Laboratories’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Luneau”

FDA records each applicant name separately; these may or may not be the same firm.

Luneau SA 5 Luneau Ophtalmologie SA 3 Luneau Gynecologie SA 1 Luneau Technology Operations 1

Luneau Laboratories

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Luneau”