Opti-Centre Laboratories: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Opti-Centre Laboratories” (first 1998, latest 2005), across 1 product code in 1 review panel. Median 510(k) review time under this name: 67 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 | 6 | 6 |
Review panels
- Ophthalmic (6)
Most recent Opti-Centre Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043129 | PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) | LPL | 2005-01-12 | 61 |
| K010256 | ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL | LPL | 2001-03-26 | 56 |
| K001227 | ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT | LPL | 2000-06-29 | 73 |
| K992589 | RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY | LPL | 1999-08-26 | 24 |
| K983496 | RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T | LPL | 1999-03-29 | 175 |
| K974599 | ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS) | LPL | 1998-03-02 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Opti-Centre Laboratories.
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 Opti-Centre Laboratories?
FDA lists 6 510(k) clearances under the applicant name “Opti-Centre Laboratories” (first 1998, latest 2005), 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 Opti-Centre Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Opti-Centre Laboratories is 67 days.
Which FDA product codes appear under Opti-Centre Laboratories?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 6).
Next steps
- See all 6 Opti-Centre Laboratories clearances with predicates and recalls
- Run predicate analysis for product code LPL, Opti-Centre Laboratories'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.