510(k) Report

FDA applicant

Luxar Medical Laser Instruments

Bothell, WA1 decision1989–19890 recalls

FDA records 1 decision for Luxar Medical Laser Instruments (Bothell, WA) in 1989: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Luxar Medical Laser Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Luxar Medical Laser Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Luxar”

FDA records each applicant name separately; these may or may not be the same firm.