Ocular Sciences Puerto Rico, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ocular Sciences Puerto Rico, Inc.” (first 1997, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time under this name: 74 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 CooperCompanies, 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 | 7 | 7 |
Review panels
- Ophthalmic (7)
Most recent Ocular Sciences Puerto Rico, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013377 | BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2001-12-20 | 69 |
| K012425 | BIOMEDICS UV MULTIFOCAL | LPL | 2001-10-12 | 74 |
| K003136 | OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | LPL | 2001-01-06 | 92 |
| K992264 | OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | LPL | 1999-11-24 | 141 |
| K982947 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS | LPL | 1999-01-29 | 161 |
| K984046 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS | LPL | 1999-01-21 | 70 |
| K972303 | OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS | LPL | 1997-08-20 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Ocular Sciences Puerto Rico, 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.
- Ocular Instruments, Inc. (50 510(k)s)
- Ocular Blood Flow Laboratories, Inc. (2 510(k)s)
- Ocular Innovations, Inc. (2 510(k)s)
- Ocular Sciences, Inc. (2 510(k)s)
- Ocular Therapeutix, Inc. (1 510(k)s)
- Ocular Concepts, LLC (1 510(k)s)
- Ocular Pharmaceuticals, Inc. (1 510(k)s)
- Ocular Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ocular Sciences Puerto Rico, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Ocular Sciences Puerto Rico, Inc.” (first 1997, latest 2001), 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 Ocular Sciences Puerto Rico, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ocular Sciences Puerto Rico, Inc. is 74 days.
Which FDA product codes appear under Ocular Sciences Puerto Rico, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 7).
Next steps
- See all 7 Ocular Sciences Puerto Rico, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Ocular Sciences Puerto Rico, 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.