510(k) Report

FDA applicant

Medtek Lighting

Coralville, IA3 decisions2005–20140 recalls

FDA records 3 decisions for Medtek Lighting (Coralville, IA) from 2005 to 2014: 3 510(k) clearances. All are in product code FTC (Light, Ultraviolet, Dermatological). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medtek Lighting Corporation”, “Medtek Lighting Corp”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2014

2012: 12014: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medtek Lighting’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 “Medtek”

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