FDA applicant
Elegance Optical Manufactory, Ltd.
FDA records 1 decision for Elegance Optical Manufactory, Ltd. (New York, NY) 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 Elegance Optical Manufactory, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Elegance Optical Manufactory, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Elegance Optical Manufactory, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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