Hoya Conbio, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Hoya Conbio, Inc.” (first 2004, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 65 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 | 8 | 8 |
Review panels
Most recent Hoya Conbio, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083899 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | GEX | 2009-06-01 | 154 |
| K073158 | SCULPTURE 2.94 ER:YAG SYSTEM | GEX | 2008-08-27 | 293 |
| K073332 | V-RASER DIODE LASER SYSTEM | GEX | 2008-02-14 | 79 |
| K063384 | DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 | GEX | 2007-03-16 | 128 |
| K063834 | REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM | GEX | 2007-01-25 | 30 |
| K063112 | REVLITE Q-SWITCHED ND:YAG LASER | GEX | 2006-12-01 | 51 |
| K060977 | MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 | GEX | 2006-05-24 | 44 |
| K041710 | VERSAWAVE DENTAL ER:YAG LASER SYSTEM | GEX | 2004-08-03 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Hoya Conbio, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Hoya Conbio, Inc. (7)
- Hoya Conbio (1)
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 Photonics, Inc. (5 510(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 Conbio, Inc.?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Hoya Conbio, Inc.” (first 2004, latest 2009), 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 Conbio, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hoya Conbio, Inc. is 65 days.
Which FDA product codes appear under Hoya Conbio, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 8).
Next steps
- See all 8 Hoya Conbio, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Hoya Conbio, 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.