Vistakon: FDA clearances and approvals
Vistakon has 5 FDA 510(k) clearances (first 2001, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time: 51 days. openFDA lists 2 product recalls by a recalling firm named Vistakon.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent Vistakon 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | 2004-10-28 | 66 |
| K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | 2004-02-04 | 44 |
| K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | LPL | 2002-02-26 | 85 |
| K010507 | VISTAKON (METHAFILCON A) CONTACT LENSES | LPL | 2001-04-12 | 50 |
| K010218 | VISTAKON (HEFILCON C) CONTACT LENSES | LPL | 2001-03-16 | 51 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-07-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vistakon have?
Vistakon has 5 FDA 510(k) clearances (first 2001, latest 2004), across 1 product code in 1 review panel.
How long does FDA take to clear Vistakon's 510(k)s?
The median time from FDA receipt to decision across Vistakon's cleared 510(k)s is 51 days.
What devices does Vistakon make?
Its most frequent FDA product codes are LPL (Lenses, Soft Contact, Daily Wear, 5).
Has Vistakon had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Vistakon; the most recent began 2010-07-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Vistakon clearances with predicates and recalls
- Run predicate analysis for product code LPL, Vistakon's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.