Unilens Corp., USA: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Unilens Corp., USA” (first 1994, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 56 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 | 1 | 122 |
| 2013 | 0 | — |
| 2014 | 1 | 30 |
| 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 | 14 | 14 |
| LPM | Lenses, Soft Contact, Extended Wear | 1 | 0 |
Review panels
- Ophthalmic (15)
Most recent Unilens Corp., USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | LPL | 2014-10-30 | 30 |
| K121652 | CVUE ADVANCED HYDRA VUE | LPL | 2012-10-05 | 122 |
| K110452 | SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, | LPL | 2011-04-20 | 63 |
| K100456 | CVUE ADVANCED DEFINITIVE | LPL | 2010-10-28 | 253 |
| K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2008-09-11 | 23 |
| K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS | LPL | 2005-04-13 | 23 |
| K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS | LPL | 2004-07-07 | 22 |
| K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS | LPL | 2000-10-17 | 71 |
| K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | LPL | 1996-04-10 | 35 |
| K960380 | SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | LPL | 1996-03-28 | 62 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890040 | PMA | SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS | 1989-09-28 |
Recalls
openFDA lists no recalls under a recalling firm named Unilens Corp., USA.
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.
- Unilens Corporation, USA (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unilens Corp., USA?
FDA lists 14 510(k) clearances under the applicant name “Unilens Corp., USA” (first 1994, latest 2014), 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 Unilens Corp., USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unilens Corp., USA is 56 days.
Which FDA product codes appear under Unilens Corp., USA?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 14); LPM (Lenses, Soft Contact, Extended Wear, 1).
Next steps
- See all 14 Unilens Corp., USA clearances with predicates and recalls
- Run predicate analysis for product code LPL, Unilens Corp., USA'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.