Company · US
Biotex, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2024. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 2024 | K233442 | troCarWash System Biotex, Inc. | OCX |
| Feb 17, 2023 | K222695 | troCarWash System Biotex, Inc. | OCX |
| Jul 20, 2021 | K203712 | The Slide Biotex, Inc. | LQZ |
| Dec 1, 2016 | K161704 | Phasor Drill Biotex, Inc. | HBE |
| Oct 6, 2009 | K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 Biotex, Inc. | GEX |
| Sep 10, 2008 | K081656 | VISUALASE THERMAL THERAPY SYSTEM Biotex, Inc. | LLZ |
| Aug 31, 2007 | K071328 | VISUALASE THERMAL THERAPY SYSTEM Biotex, Inc. | GEX |
| Dec 12, 2006 | K063505 | VISUALASE ENVISION SOFTWARE SYSTEM Biotex, Inc. | LLZ |
| Mar 21, 2006 | K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 Biotex, Inc. | GEX |
| Mar 1, 2006 | K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM Biotex, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||