510(k) Report

FDA applicant

Lysonix, Inc.

Carpinteria, CA5 decisions1997–19980 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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.

FIG. 1 — Lysonix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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