FDA applicant
St. shine Optical Co., Ltd.
FDA records 11 decisions for St. shine Optical Co., Ltd. (New Taipei City, TW) from 2002 to 2026: 11 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 8 of them its own earlier devices. 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 St. shine Optical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like St. shine 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