Kontur Kontact Lens Co., Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Kontur Kontact Lens Co., Inc.” (first 2000, latest 2000), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 | 1 | 1 |
| LPM | Lenses, Soft Contact, Extended Wear | 1 | 0 |
Review panels
- Ophthalmic (2)
Most recent Kontur Kontact Lens Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001908 | KONTUR 55 SOFT LENS | LPL | 2000-08-18 | 57 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850078 | PMA | KONTUR 55 EW | 1986-01-31 |
Recalls
openFDA lists no recalls under a recalling firm named Kontur Kontact 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kontur Kontact Lens Co., Inc.?
FDA lists 1 510(k) clearance under the applicant name “Kontur Kontact Lens Co., Inc.” (first 2000, latest 2000), 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 Kontur Kontact Lens Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kontur Kontact Lens Co., Inc. is 57 days.
Which FDA product codes appear under Kontur Kontact Lens Co., Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 1); LPM (Lenses, Soft Contact, Extended Wear, 1).
Next steps
- See all 1 Kontur Kontact Lens Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Kontur Kontact 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.