Innova Vision, Inc.: FDA clearances and approvals
Innova Vision, Inc. has 11 FDA 510(k) clearances (first 2004, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time: 167 days. Since 2017 its median was 144 days, against 111 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 366 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 228 |
| 2023 | 2 | 144 |
| 2024 | 1 | 54 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Innova Vision, Inc.'s cleared 510(k)s took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 9 | 9 |
| MVN | Lens, Contact, (Disposable) | 2 | 2 |
Review panels
- Ophthalmic (11)
Most recent Innova Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | LPL | 2024-04-17 | 54 |
| K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | LPL | 2023-11-16 | 121 |
| K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | LPL | 2023-03-13 | 167 |
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | LPL | 2022-05-13 | 228 |
| K112373 | CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION | LPL | 2012-08-17 | 366 |
| K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER | LPL | 2009-09-03 | 300 |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | MVN | 2007-11-29 | 30 |
| K062541 | CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2007-06-07 | 281 |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | MVN | 2006-05-12 | 178 |
| K051129 | DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | 2005-08-12 | 101 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innova Vision, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Innova Vision, Inc. have?
Innova Vision, Inc. has 11 FDA 510(k) clearances (first 2004, latest 2024), across 2 product codes in 1 review panel.
How long does FDA take to clear Innova Vision, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Innova Vision, Inc.'s cleared 510(k)s is 167 days. Since 2017: 144 days, versus 111 days for all cleared 510(k)s in the same product codes.
What devices does Innova Vision, Inc. make?
Its most frequent FDA product codes are LPL (Lenses, Soft Contact, Daily Wear, 9); MVN (Lens, Contact, (Disposable), 2).
Has Innova Vision, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Innova Vision, Inc. Related entities may recall under other names.
Next steps
- See all 11 Innova Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Innova Vision, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.