FDA applicant
Pegavision Corporation
FDA records 14 decisions for Pegavision Corporation (Taoyuan City, TW) from 2012 to 2026: 14 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 225 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 9 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 Pegavision Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Pegavision Corporation’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