FDA applicant
Visco Vision, Inc.
FDA records 12 decisions for Visco Vision, Inc. (Taoyuan City, TW) from 2015 to 2026: 12 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 15 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 Visco Vision, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Visco Vision, Inc.’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