Sauflon Pharmaceuticals, Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Sauflon Pharmaceuticals, Ltd.” (first 1999, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CooperCompanies, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 165 |
| 2014 | 1 | 86 |
| 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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | 4 | 4 |
| LPL | Lenses, Soft Contact, Daily Wear | 3 | 3 |
| LRX | Case, Contact Lens | 2 | 2 |
| MVN | Lens, Contact, (Disposable) | 2 | 2 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 1 | 1 |
Review panels
- Ophthalmic (12)
Most recent Sauflon Pharmaceuticals, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133740 | SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT | LPL | 2014-03-05 | 86 |
| K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | 2013-08-05 | 175 |
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | MVN | 2013-07-26 | 165 |
| K130734 | SAUFLON MULTIPURPOSE SOLUTION | LPN | 2013-05-15 | 58 |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES | MVN | 2006-05-15 | 221 |
| K052809 | SAUFLON FLAT COLOURED LENS CASE | LRX | 2005-11-02 | 29 |
| K033656 | SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE | LRX | 2004-02-02 | 73 |
| K030278 | SAUFLON MULTIPURPOSE SOLUTION - NO RUB | LPN | 2003-07-30 | 184 |
| K013649 | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2001-12-26 | 51 |
| K010559 | SAUFLON MULTI LENS CARE SYSTEM | LPN | 2001-12-20 | 297 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sauflon Pharmaceuticals, 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.
Device clinical trials
An industry sponsor named Sauflon Pharmaceuticals, Ltd. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01996787: Clinical Study of Visibility Tinted Clariti Contact Lens (Completed, started 2013-06)
- NCT01392950: Clinical Study of Clariti Monthly Contact Lens (Completed, started 2010-09)
- NCT01392937: Clinical Performance of All-in-One Light Multi-purpose for Silicone Hydrogel Contact Lenses (Completed, started 2010-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sauflon Pharmaceuticals, Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Sauflon Pharmaceuticals, Ltd.” (first 1999, latest 2014), across 5 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 Sauflon Pharmaceuticals, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sauflon Pharmaceuticals, Ltd. is 126 days.
Which FDA product codes appear under Sauflon Pharmaceuticals, Ltd.?
The most frequent FDA product codes under this applicant name are LPN (Accessories, Soft Lens Products, 4); LPL (Lenses, Soft Contact, Daily Wear, 3); LRX (Case, Contact Lens, 2).
Next steps
- See all 12 Sauflon Pharmaceuticals, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPN, Sauflon Pharmaceuticals, 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.