FDA applicant
Laser Surgical Systems
FDA records 3 decisions for Laser Surgical Systems (San Jose, CA) from 1992 to 1994: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). 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 Laser Surgical Systems’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Laser Surgical Systems since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Laser Surgical Systems’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) ReportOther applicant names beginning “Laser”
FDA records each applicant name separately; these may or may not be the same firm.