Hoya Photonics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hoya Photonics, Inc.” (first 2004, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
Review panels
Most recent Hoya Photonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103118 | REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR | GEX | 2010-11-19 | 29 |
| K050696 | MEDLITE C1 Q-SWITCHED ND:YAG LASER | GEX | 2005-06-17 | 91 |
| K050274 | DIODENT II DENTAL LASER SYSTEM | GEX | 2005-04-29 | 81 |
| K041721 | LVI AESTHETIC LASER | GEX | 2004-08-05 | 42 |
| K032797 | DELIGHT DENTAL ER: YAG LASER SYSTEM | GEX | 2004-04-05 | 210 |
Recalls
openFDA lists no recalls under a recalling firm named Hoya Photonics, 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.
- Hoya Conbio, Inc. (8 510(k)s)
- HOYA Lamphun , Ltd. (2 510(k)s)
- Hoya Surgical Optics, Inc. (1 510(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 Photonics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Hoya Photonics, Inc.” (first 2004, latest 2010), 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 Hoya Photonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hoya Photonics, Inc. is 81 days.
Which FDA product codes appear under Hoya Photonics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Hoya Photonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Hoya Photonics, 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.