FDA applicant
Lysonix, Inc.
FDA records 5 decisions for Lysonix, Inc. (Carpinteria, CA) from 1997 to 1998: 5 510(k) clearances. Most are in product codes QPB (System, Suction, Lipoplasty For Removal) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). Its devices cite 6 predicates, 0 of them its own earlier devices. 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 Lysonix, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Lysonix, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lysonix, 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