Pegavision Corporation: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Pegavision Corporation” (first 2012, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 218 days. Since 2017 the median was 229 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 |
|---|---|---|
| 2012 | 1 | 104 |
| 2013 | 1 | 118 |
| 2014 | 1 | 282 |
| 2015 | 0 | — |
| 2016 | 1 | 178 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 252 |
| 2021 | 1 | 210 |
| 2022 | 1 | 254 |
| 2023 | 1 | 250 |
| 2024 | 1 | 251 |
| 2025 | 2 | 178 |
| 2026 | 3 | 225 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pegavision Corporation took a median 229 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 | 14 | 14 |
Review panels
- Ophthalmic (14)
Most recent Pegavision Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses | LPL | 2026-05-21 | 233 |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | LPL | 2026-05-19 | 29 |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | LPL | 2026-03-13 | 225 |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | LPL | 2025-09-17 | 160 |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | LPL | 2025-07-02 | 197 |
| K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | LPL | 2024-05-08 | 251 |
| K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | LPL | 2023-05-31 | 250 |
| K211603 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | LPL | 2022-02-02 | 254 |
| K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | LPL | 2021-12-06 | 210 |
| K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses | LPL | 2020-10-15 | 252 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pegavision Corporation.
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 Pegavision Corporation?
FDA lists 14 510(k) clearances under the applicant name “Pegavision Corporation” (first 2012, latest 2026), 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 Pegavision Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pegavision Corporation is 218 days. Since 2017: 229 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pegavision Corporation?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 14).
Next steps
- See all 14 Pegavision Corporation clearances with predicates and recalls
- Run predicate analysis for product code LPL, Pegavision Corporation'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.