510(k) Report

FDA applicant

Lasermatic, Inc.

Dallas, TX10 decisions1988–19910 recalls

FDA records 10 decisions for Lasermatic, Inc. (Dallas, TX) from 1988 to 1991: 10 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LNK (Laser For Gastro-Urology Use). No recall is linked to its devices.

FDA’s records also spell it “Lasermatic OY”.

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 Lasermatic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lasermatic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lasermatic, 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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