FDA applicant
Icn Photonics, Ltd.
FDA records 4 decisions for Icn Photonics, Ltd. (Llanelli, GB) from 2002 to 2003: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 5 predicates, 1 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 Icn Photonics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Icn Photonics, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Icn Photonics, Ltd.’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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