FDA applicant
Largan Medical Co., Ltd.
FDA records 8 decisions for Largan Medical Co., Ltd. (Taichung, TW) from 2017 to 2025: 8 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and MNR (Ventilatory Effort Recorder). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 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 Largan Medical 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 2017.
Planning a device like Largan Medical Co., 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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