Ocu-Ease Optical Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Ocu-Ease Optical Products, Inc.” (first 1994, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 57 days. 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 | 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 | 9 | 9 |
Review panels
- Ophthalmic (9)
Most recent Ocu-Ease Optical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023077 | OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) | LPL | 2002-12-10 | 85 |
| K020690 | OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS | LPL | 2002-04-26 | 53 |
| K011577 | OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S | LPL | 2001-06-19 | 28 |
| K004000 | OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT | LPL | 2001-02-21 | 57 |
| K003996 | OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR | LPL | 2001-02-21 | 57 |
| K002966 | OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR | LPL | 2000-11-08 | 47 |
| K992466 | OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR | LPL | 1999-10-04 | 73 |
| K960291 | TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS | LPL | 1996-03-25 | 63 |
| K941998 | OCU-FLEX-38 (POLYMACON) | LPL | 1994-10-13 | 171 |
Recalls
openFDA lists no recalls under a recalling firm named Ocu-Ease Optical 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ocu-Ease Optical Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Ocu-Ease Optical Products, Inc.” (first 1994, latest 2002), 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 Ocu-Ease Optical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ocu-Ease Optical Products, Inc. is 57 days.
Which FDA product codes appear under Ocu-Ease Optical Products, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 9).
Next steps
- See all 9 Ocu-Ease Optical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Ocu-Ease Optical 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 (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.