FDA applicant
Iriderm Div.
FDA records 10 decisions for Iriderm Div. (Mountain View, CA) from 1989 to 1997: 10 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQF (Laser, Ophthalmic). Its devices cite 11 predicates, 3 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 Iriderm Div.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Iriderm Div. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Iriderm Div.’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