Luxtec Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Luxtec Corp.” (first 1986, latest 1997), across 10 product codes in 6 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | 3 | 3 |
| FCW | Light Source, Fiberoptic, Routine | 2 | 2 |
| FSP | Loupe, Diagnostic/Surgical | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
| FST | Light, Surgical, Fiberoptic | 1 | 1 |
| FWC | Camera, Television, Surgical, With Audio | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| HDG | Speculum, Vaginal, Metal, Fiberoptic | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Review panels
- General and Plastic Surgery (5)
- Ear, Nose and Throat (3)
- Gastroenterology and Urology (3)
- Orthopedic (2)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
Most recent Luxtec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973193 | LUXSCOPE | HQF | 1997-11-21 | 88 |
| K970642 | TENOSCOPE | HRX | 1997-05-21 | 90 |
| K970562 | TENOSNARE | HRX | 1997-05-14 | 90 |
| K950960 | REDDY ILLUMINATOR | FFS | 1995-09-08 | 190 |
| K895248 | IMS5000 ILLUMINATED LOUPES | FSP | 1989-09-15 | 25 |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | FCW | 1989-04-26 | 72 |
| K864387 | LUXTEC FIBEROPTIC CABLES | EQH | 1987-05-22 | 198 |
| K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS | EQH | 1987-01-14 | 70 |
| K864382 | FRAZIER SUCTION TUBE | EQH | 1987-01-14 | 70 |
| K864385 | LUXTEC LIGHT SOURCES | FCW | 1987-01-13 | 69 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Luxtec 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Luxtec Corp.?
FDA lists 15 510(k) clearances under the applicant name “Luxtec Corp.” (first 1986, latest 1997), across 10 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Luxtec Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Luxtec Corp. is 70 days.
Which FDA product codes appear under Luxtec Corp.?
The most frequent FDA product codes under this applicant name are EQH (Source, Carrier, Fiberoptic Light, 3); FCW (Light Source, Fiberoptic, Routine, 2); FSP (Loupe, Diagnostic/Surgical, 2).
Next steps
- See all 15 Luxtec Corp. clearances with predicates and recalls
- Run predicate analysis for product code EQH, Luxtec 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.