FDA applicant
Psoria-Shield, Inc.
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
How often FDA has decided Psoria-Shield, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
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.
See the 510(k) Report