Vizionfocus, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vizionfocus, Inc.” (first 2018, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 111 days, against 113 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 53 |
| 2019 | 1 | 115 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 125 |
| 2025 | 2 | 110 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vizionfocus, Inc. took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent Vizionfocus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | LPL | 2025-09-10 | 111 |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | LPL | 2025-04-10 | 108 |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | LPL | 2024-12-17 | 125 |
| K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses | LPL | 2019-12-09 | 115 |
| K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) | LPL | 2018-10-12 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Vizionfocus, 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 Vizionfocus, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Vizionfocus, Inc.” (first 2018, latest 2025), 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 Vizionfocus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vizionfocus, Inc. is 111 days. Since 2017: 111 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vizionfocus, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 5).
Next steps
- See all 5 Vizionfocus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Vizionfocus, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.