FDA applicant
Coherent Star
FDA records 2 decisions for Coherent Star (Pleasanton, CA) from 2000 to 2001: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Coherent Star’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Coherent Star since 2007.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Coherent Star’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 “Coherent”
FDA records each applicant name separately; these may or may not be the same firm.