FDA applicant
Soft-Core Texas, Inc.
FDA records 2 decisions for Soft-Core Texas, Inc. (North Richland Hills, TX) from 2000 to 2003: 2 510(k) clearances. Most are in product codes NHN (Powered Light Based Laser Non-Thermal…) and EBZ (Activator, Ultraviolet, For Polymerization). 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 Soft-Core Texas, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Soft-Core Texas, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Soft-Core Texas, 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) ReportOther applicant names beginning “Soft-Core”
FDA records each applicant name separately; these may or may not be the same firm.