510(k) Report

FDA applicant

Omnilight, Inc.

Placitas,, NM1 decision2004–20040 recalls

FDA records 1 decision for Omnilight, Inc. (Placitas,, NM) in 2004: 1 510(k) clearance. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). 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, physical medicine panel, where it files most

How often FDA has decided Omnilight, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omnilight, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Omnilight, Inc.’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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