FDA applicant
Seiko Optical Products of America, Inc.
FDA records 4 decisions for Seiko Optical Products of America, Inc. (Mahwah, NJ) from 1986 to 1994: 4 510(k) clearances. Most are in product codes HQG (Lens, Spectacle, Non-Custom (Prescription)) 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 Seiko Optical Products of America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Seiko Optical Products of America, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Seiko Optical Products of America, 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 “Seiko”
FDA records each applicant name separately; these may or may not be the same firm.