Vistakon, Johnson & Johnson Vision Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Vistakon, Johnson & Johnson Vision Products, Inc.” (first 1995, latest 2000), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 Johnson & Johnson MedTech, based on public ownership records.
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 | 8 | 8 |
| LPM | Lenses, Soft Contact, Extended Wear | 1 | 0 |
Review panels
- Ophthalmic (9)
Most recent Vistakon, Johnson & Johnson Vision Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994324 | ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPL | 2000-02-23 | 63 |
| K994318 | VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPL | 2000-02-23 | 63 |
| K991163 | VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR | LPL | 1999-06-08 | 62 |
| K991134 | ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR | LPL | 1999-05-06 | 34 |
| K983912 | VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER | LPL | 1999-01-26 | 84 |
| K964612 | VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT | LPL | 1997-01-30 | 73 |
| K962804 | ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER | LPL | 1996-10-01 | 75 |
| K953804 | VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS | LPL | 1995-09-26 | 49 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N18033 | PMA | ACUVUE CONTACT LENS | 1980-03-18 |
Recalls
openFDA lists no recalls under a recalling firm named Vistakon, Johnson & Johnson Vision Products, 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.
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.
- Vistakon (5 510(k)s)
- Vistakon, Division of Johnson & Johnson Vision Car (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vistakon, Johnson & Johnson Vision Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Vistakon, Johnson & Johnson Vision Products, Inc.” (first 1995, 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 Vistakon, Johnson & Johnson Vision Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vistakon, Johnson & Johnson Vision Products, Inc. is 63 days.
Which FDA product codes appear under Vistakon, Johnson & Johnson Vision Products, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 8); LPM (Lenses, Soft Contact, Extended Wear, 1).
Next steps
- See all 8 Vistakon, Johnson & Johnson Vision Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Vistakon, Johnson & Johnson Vision Products, 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.