FDA applicant
Summit Optics, Inc.
FDA records 2 decisions for Summit Optics, Inc. (Walker, MI) from 1980 to 1987: 2 510(k) clearances. Most are in product codes KYG (Device, Irrigation, Ocular Surgery) and HQY (Sunglasses (Non-Prescription Including…). 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 Summit Optics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Summit Optics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Summit Optics, Inc.’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 “Summit”
FDA records each applicant name separately; these may or may not be the same firm.