FDA applicant
Psoralite Corp.
FDA records 5 decisions for Psoralite Corp. (Columbia, SC) from 1987 to 1991: 5 510(k) clearances. All are in product code FTC (Light, Ultraviolet, Dermatological). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Psoralite Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Psoralite Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Psoralite Corp.’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