Soflex Contact Lens Industries , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Soflex Contact Lens Industries , Ltd.” (first 2001, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 82 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 | 6 | 6 |
Review panels
- Ophthalmic (6)
Most recent Soflex Contact Lens Industries , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033655 | SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR | LPL | 2004-07-30 | 252 |
| K030842 | ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP | LPL | 2003-06-06 | 81 |
| K020642 | SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR | LPL | 2002-05-24 | 86 |
| K013469 | EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR | LPL | 2001-11-20 | 33 |
| K013467 | TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR | LPL | 2001-11-20 | 33 |
| K011256 | TORIC LITE LENS | LPL | 2001-07-17 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Soflex Contact Lens Industries , Ltd..
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.
- Soflex Limited (3 510(k)s)
- Soflex Isralens Contact Lens , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Soflex Contact Lens Industries , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Soflex Contact Lens Industries , Ltd.” (first 2001, latest 2004), across 1 product code 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 Soflex Contact Lens Industries , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Soflex Contact Lens Industries , Ltd. is 82 days.
Which FDA product codes appear under Soflex Contact Lens Industries , Ltd.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 6).
Next steps
- See all 6 Soflex Contact Lens Industries , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Soflex Contact Lens Industries , Ltd.'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.