Westcon Contact Lens Co., Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Westcon Contact Lens Co., Inc.” (first 1994, latest 2008), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 49 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
| LPM | Lenses, Soft Contact, Extended Wear | 1 | 0 |
Review panels
- Ophthalmic (11)
Most recent Westcon Contact Lens Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080686 | WESTCON HORIZON 49% (HIOXIFILCON B) | LPL | 2008-04-22 | 42 |
| K043540 | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES | LPL | 2005-02-01 | 41 |
| K031774 | HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES | LPL | 2004-02-20 | 256 |
| K023530 | HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) | LPL | 2002-11-26 | 36 |
| K992010 | W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) | LPL | 1999-06-29 | 14 |
| K963837 | HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN | LPL | 1996-12-20 | 87 |
| K962121 | HORIZON/WESTHIN 55-G | LPL | 1996-08-26 | 87 |
| K954524 | W-55 (METHAFILON A) CONTACT LENS | LPL | 1996-03-28 | 181 |
| K950818 | HORIZON 55 BI-CON TORIC | LPL | 1995-03-21 | 26 |
| K945365 | HORIZON 55 BI-CON | LPL | 1994-12-28 | 56 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990072 | PMA | W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES | 2000-08-22 |
Recalls
openFDA lists no recalls under a recalling firm named Westcon Contact Lens Co., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Westcon Orthopedics, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Westcon Contact Lens Co., Inc.?
FDA lists 10 510(k) clearances under the applicant name “Westcon Contact Lens Co., Inc.” (first 1994, latest 2008), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Westcon Contact Lens Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Westcon Contact Lens Co., Inc. is 49 days.
Which FDA product codes appear under Westcon Contact Lens Co., Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 10); LPM (Lenses, Soft Contact, Extended Wear, 1).
Next steps
- See all 10 Westcon Contact Lens Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Westcon Contact Lens Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.