FDA applicant
Laserscope
FDA records 60 decisions for Laserscope (San Jose, CA) from 1985 to 2006: 60 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LNK (Laser For Gastro-Urology Use). Its devices cite 7 predicates, 4 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Laserscope’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Laserscope since 2007.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Laserscope’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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