Paragon Vision Sciences: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Paragon Vision Sciences” (first 1994, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 87 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 | 1 | 87 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 53 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 322 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paragon Vision Sciences took a median 188 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 74 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 11 | 11 |
| LRX | Case, Contact Lens | 3 | 3 |
| MUW | Lens, Contact (Orthokeratology) | 2 | 2 |
Review panels
- Ophthalmic (16)
Most recent Paragon Vision Sciences 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | HQD | 2023-05-05 | 322 |
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG | HQD | 2018-03-16 | 53 |
| K120996 | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN | HQD | 2012-06-28 | 87 |
| K082799 | HDS HI 1.54 | HQD | 2009-01-27 | 126 |
| K070637 | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES | HQD | 2007-05-01 | 55 |
| K052983 | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES | HQD | 2006-02-10 | 109 |
| K013310 | PVS BASIC 2; EPIC 2 | HQD | 2002-04-25 | 203 |
| K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK | MUW | 2001-02-28 | 47 |
| K002845 | PAFLUFOCON C AND E DAILY CONTACT LENS | HQD | 2000-12-08 | 87 |
| K993586 | SPORTSIGHT GP | HQD | 2000-05-22 | 213 |
6 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2023-06-26.
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.
- Paragon 28, Inc. (60 510(k)s)
- Paragon Trade Brands, Inc. (14 510(k)s)
- Paragon Diagnostics, Inc. (7 510(k)s)
- Paragon Implant Mfg., LLC (5 510(k)s)
- Paragon Medical (5 510(k)s)
- Paragon Optical Co. (1 510(k)s)
- Paragon Bioteck, Inc. (1 510(k)s)
- Paragon Medical and Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paragon Vision Sciences?
FDA lists 16 510(k) clearances under the applicant name “Paragon Vision Sciences” (first 1994, latest 2023), across 3 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 Paragon Vision Sciences?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paragon Vision Sciences is 87 days.
Which FDA product codes appear under Paragon Vision Sciences?
The most frequent FDA product codes under this applicant name are HQD (Lens, Contact (Other Material) - Daily, 11); LRX (Case, Contact Lens, 3); MUW (Lens, Contact (Orthokeratology), 2).
Next steps
- See all 16 Paragon Vision Sciences clearances with predicates and recalls
- Run predicate analysis for product code HQD, Paragon Vision Sciences'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.