Polycore Optical Pte , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Polycore Optical Pte , Ltd.” (first 1979, latest 1983), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 126 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 |
|---|---|---|---|
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (1)
Most recent Polycore Optical Pte , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832461 | POLYCORE | — | 1983-08-16 | 21 |
| K822542 | POLYCORE | — | 1982-12-27 | 126 |
| K822541 | VISIOPAL 75 | — | 1982-12-27 | 126 |
| K822431 | SUNGLASS & SAFETY PLANO LENS | — | 1982-12-27 | 137 |
| K822430 | KRYPTOX-ROUND SEGMENT BIFOCAL | — | 1982-12-27 | 137 |
| K822429 | SINGLE VISION POWER LENS | — | 1982-12-27 | 137 |
| K790215 | LENS, POLYCORE | HQG | 1979-02-26 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Polycore Optical Pte , Ltd..
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 Polycore Optical Pte , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Polycore Optical Pte , Ltd.” (first 1979, latest 1983), across 2 product codes 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 Polycore Optical Pte , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polycore Optical Pte , Ltd. is 126 days.
Which FDA product codes appear under Polycore Optical Pte , Ltd.?
The most frequent FDA product codes under this applicant name are HQG (Lens, Spectacle, Non-Custom (Prescription), 1).
Next steps
- See all 7 Polycore Optical Pte , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HQG, Polycore Optical Pte , Ltd.'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.