Luxar Corp.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Luxar Corp.” (first 1988, latest 1996), across 1 product code in 1 review panel. Median 510(k) review time under this name: 57 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 | 17 | 17 |
Review panels
Most recent Luxar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960475 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | GEX | 1996-04-26 | 85 |
| K953074 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | GEX | 1995-08-28 | 59 |
| K945888 | MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM | GEX | 1995-01-27 | 57 |
| K904068 | LUXAR MODEL LX-20 CO2 LASER | GEX | 1991-04-15 | 227 |
| K903079 | ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM) | GEX | 1990-10-04 | 84 |
| K900066 | FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER | GEX | 1990-03-19 | 74 |
| K897040 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.) | GEX | 1990-02-13 | 57 |
| K896478 | LUXAR MODEL LX-20 MINILASE CO2 LASER | GEX | 1990-02-08 | 87 |
| K896711 | LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE | GEX | 1990-01-09 | 42 |
| K896619 | LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE | GEX | 1990-01-09 | 49 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Luxar Corp..
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.
- Luxar Medical Laser Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Luxar Corp.?
FDA lists 17 510(k) clearances under the applicant name “Luxar Corp.” (first 1988, latest 1996), 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 Luxar Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Luxar Corp. is 57 days.
Which FDA product codes appear under Luxar Corp.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 17).
Next steps
- See all 17 Luxar Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Luxar Corp.'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.