FDA applicant
Royal Flash Enterprise Co., Ltd.
FDA records 1 decision for Royal Flash Enterprise Co., Ltd. (Tainan City, TW) in 1995: 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 Royal Flash Enterprise Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Royal Flash Enterprise Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Royal Flash Enterprise 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) ReportOther applicant names beginning “Royal”
FDA records each applicant name separately; these may or may not be the same firm.