510(k) Report

FDA applicant

Psoria-Shield, Inc.

Utica, NY3 decisions2011–20230 recalls

FDA records 3 decisions for Psoria-Shield, Inc. (Utica, NY) from 2011 to 2023: 3 510(k) clearances. All are in product code FTC (Light, Ultraviolet, Dermatological). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Psoria-Shield”.

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 Psoria-Shield, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011: 12020: 12023: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Psoria-Shield, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Psoria-Shield, 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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