FDA applicant
Aculux
FDA records 2 decisions for Aculux (Naples, FL) from 2000 to 2002: 2 510(k) clearances. Most are in product codes FQP (Lamp, Operating-Room) and FSW (Light, Surgical, Endoscopic). No recall is linked to its devices.
FDA’s records also spell it “Aculux, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aculux’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Aculux since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Aculux’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