FDA applicant
Nova Eye Inc. (Business Name Nova Eye Medical)
FDA records 1 decision for Nova Eye Inc. (Business Name Nova Eye Medical) (Fremont, CA) in 2023: 1 510(k) clearance. All are in product code MPA (Endoilluminator). Its devices cite 1 predicate, 0 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 Nova Eye Inc. (Business Name Nova Eye Medical)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Nova Eye Inc. (Business Name Nova Eye…’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 “Nova”
FDA records each applicant name separately; these may or may not be the same firm.