FDA applicant
Lasermatic, Inc.
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
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.
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.
See the 510(k) Report