FDA applicant
Pacific Optical Co., Ltd.
FDA records 1 decision for Pacific Optical Co., Ltd. (Wenzhou, Zhejiang, CN) in 1997: 1 510(k) clearance. All are in product code 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 Pacific Optical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pacific Optical Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pacific Optical Co., Ltd.’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) Report