Biotex, Inc.
Houston, TX, US
BIOTEX, INC. appears in FDA device records in Houston, TX. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Biotex, Inc. between 2006 and 2024. The busiest year on record is 2006, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2016 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233442 | troCarWash™ System | OCX | Substantially Equivalent | |
| K222695 | troCarWash™ System | OCX | Substantially Equivalent | |
| K203712 | The Slide | LQZ | Substantially Equivalent | |
| K161704 | Phasor Drill | HBE | Substantially Equivalent | |
| K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 | GEX | Substantially Equivalent | |
| K081656 | VISUALASE THERMAL THERAPY SYSTEM | LLZ | Substantially Equivalent | |
| K071328 | VISUALASE THERMAL THERAPY SYSTEM | GEX | Substantially Equivalent | |
| K063505 | VISUALASE ENVISION SOFTWARE SYSTEM | LLZ | Substantially Equivalent | |
| K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 | GEX | Substantially Equivalent | |
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005726841 | 3005726841 | BIOTEX, INC. | 114 Holmes Rd, HOUSTON, TX 77045 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- LRKDevice, Anti-Snoring
- LQZDevice, Jaw Repositioning
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- OCXEndoscopic Irrigation/Suction System
- FTDLamp, Surgical
- GEXPowered Laser Surgical Instrument
- FEQPump, Air, Non-Manual, For Endoscope
- LLZSystem, Image Processing, Radiological
- EHYTray, Impression, Preformed
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain