FDA applicant
American Laser Corp.
FDA records 5 decisions for American Laser Corp. (Salt Lake City, UT) from 1982 to 2001: 5 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQF (Laser, Ophthalmic). Its devices cite 2 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 American Laser Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Laser Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Laser Corp.’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