FDA applicant
Laserguide
FDA records 5 decisions for Laserguide (Santa Barbara, CA) from 1987 to 1988: 5 510(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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Laserguide’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Laserguide since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Laserguide’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