Wesley Jessen Corp.: FDA clearances and approvals
Wesley Jessen Corp. has 11 FDA 510(k) clearances (first 1987, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time: 88 days.
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 | 10 | 10 |
| LPN | Accessories, Soft Lens Products | 1 | 1 |
Review panels
- Ophthalmic (11)
Most recent Wesley Jessen Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994335 | PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2000-03-20 | 88 |
| K000439 | DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C | LPL | 2000-03-20 | 39 |
| K993935 | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI | LPL | 1999-12-21 | 32 |
| K991000 | GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES | LPL | 1999-06-28 | 96 |
| K991550 | FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS | LPL | 1999-05-14 | 10 |
| K982988 | PRECISION UV (VASURFILCON A) | LPL | 1999-01-06 | 133 |
| K982344 | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS | LPL | 1998-12-22 | 169 |
| K965052 | D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES | LPL | 1997-05-14 | 147 |
| K962957 | RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT | LPL | 1996-10-01 | 63 |
| K954603 | DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT | LPL | 1996-01-04 | 92 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wesley Jessen Corp..
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 Wesley Jessen Corp. have?
Wesley Jessen Corp. has 11 FDA 510(k) clearances (first 1987, latest 2000), across 2 product codes in 1 review panel.
How long does FDA take to clear Wesley Jessen Corp.'s 510(k)s?
The median time from FDA receipt to decision across Wesley Jessen Corp.'s cleared 510(k)s is 88 days.
What devices does Wesley Jessen Corp. make?
Its most frequent FDA product codes are LPL (Lenses, Soft Contact, Daily Wear, 10); LPN (Accessories, Soft Lens Products, 1).
Has Wesley Jessen Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Wesley Jessen Corp. Related entities may recall under other names.
Next steps
- See all 11 Wesley Jessen Corp. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Wesley Jessen Corp.'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.