Avex Industries , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Avex Industries , Ltd.” (first 1995, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time under this name: 554 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 6 | 6 |
Review panels
Most recent Avex Industries , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935525 | PHOTOTHERAPEUTIX MODEL 2480AB | FTC | 1995-05-19 | 549 |
| K933954 | PHOTOTHERAPEUTIX MODEL 2400B | FTC | 1995-02-21 | 558 |
| K933953 | PHOTOTHERAPEUTIX MODEL 1650B | FTC | 1995-02-21 | 558 |
| K933952 | PHOTOTHERAPEUTIX MODEL 800B | FTC | 1995-02-21 | 558 |
| K935526 | PHOTOTHERAPEUTIX MODEL 1600B | FTC | 1995-02-17 | 458 |
| K935524 | PHOTOTHERAPEUTIX MODEL 3200A | FTC | 1995-02-17 | 458 |
Recalls
openFDA lists no recalls under a recalling firm named Avex Industries , 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 Avex Industries , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Avex Industries , Ltd.” (first 1995, latest 1995), 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 Avex Industries , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avex Industries , Ltd. is 554 days.
Which FDA product codes appear under Avex Industries , Ltd.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 6).
Next steps
- See all 6 Avex Industries , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Avex Industries , 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 (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.