Visco Vision, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Visco Vision, Inc.” (first 2015, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 131 days. Since 2017 the median was 126 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 |
|---|---|---|
| 2015 | 1 | 396 |
| 2016 | 2 | 187 |
| 2017 | 1 | 203 |
| 2018 | 3 | 96 |
| 2019 | 2 | 196 |
| 2020 | 2 | 178 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Visco Vision, Inc. took a median 126 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 | 11 | 11 |
Review panels
- Ophthalmic (11)
Most recent Visco Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | LPL | 2020-12-07 | 273 |
| K201080 | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens | LPL | 2020-07-15 | 84 |
| K191397 | OxySoft (olifilcon C) silicone hydrogel soft contact lens | LPL | 2019-10-02 | 131 |
| K183670 | Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens | LPL | 2019-09-13 | 260 |
| K181349 | Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens | LPL | 2018-09-19 | 121 |
| K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | LPL | 2018-04-20 | 74 |
| K173958 | OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens | LPL | 2018-04-03 | 96 |
| K171447 | OxyPure Color Silicone Hydrogel Soft Contact Lenses | LPL | 2017-12-05 | 203 |
| K160245 | Visco (olifilcon A) soft contact lens | LPL | 2016-10-24 | 266 |
| K160344 | Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 | LPL | 2016-05-26 | 108 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Visco Vision, 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.
Device clinical trials
An industry sponsor named Visco Vision, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06716385: A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact Lens (Completed, started 2024-10-09)
- NCT06716372: A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel Soft Contact Lens (Completed, started 2024-10-07)
- NCT03934788: the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens (Completed, started 2018-09-26)
- NCT03139201: Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens (Completed, started 2016-09-21)
- NCT02676258: Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens (Completed, started 2015-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Visco Vision, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Visco Vision, Inc.” (first 2015, latest 2020), 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 Visco Vision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Visco Vision, Inc. is 131 days. Since 2017: 126 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Visco Vision, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 11).
Next steps
- See all 11 Visco Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Visco Vision, 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.