Hoya Surgical Optics, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Hoya Surgical Optics, Inc.” (first 2009, latest 2009), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 313 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 |
|---|---|---|---|
| HQL | Intraocular Lens | 1 | 0 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 |
Review panels
- Ophthalmic (2)
Most recent Hoya Surgical Optics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081346 | HOYA IS INJECTOR SYSTEM | MSS | 2009-03-23 | 313 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P080004 | PMA | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | 2008-09-26 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-06-17.
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.
Device clinical trials
An industry sponsor named Hoya Surgical Optics, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01544777: Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study (Completed, started 2012-02)
- NCT01292629: Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls. (Completed, started 2011-02)
- NCT01268540: Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses (Completed, started 2010-12)
- NCT00625313: Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens (Completed, started 2004-03)
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.
- Hoya Conbio, Inc. (8 510(k)s)
- Hoya Photonics, Inc. (5 510(k)s)
- HOYA Lamphun , Ltd. (2 510(k)s)
- Hoya Corporation (1 510(k)s)
- Hoya Corp. USA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hoya Surgical Optics, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Hoya Surgical Optics, Inc.” (first 2009, latest 2009), plus 1 PMA decision, 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 Hoya Surgical Optics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hoya Surgical Optics, Inc. is 313 days.
Which FDA product codes appear under Hoya Surgical Optics, Inc.?
The most frequent FDA product codes under this applicant name are HQL (Intraocular Lens, 1); MSS (Folders And Injectors, Intraocular Lens (Iol), 1).
Next steps
- See all 1 Hoya Surgical Optics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Hoya Surgical Optics, 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.