510(k) Report

FDA applicant

Biotex, Inc.

Houston, TX10 decisions2006–20248 recalls

FDA records 10 decisions for Biotex, Inc. (Houston, TX) from 2006 to 2024: 10 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LLZ (System, Image Processing, Radiological). Its devices cite 17 predicates, 6 of them its own earlier devices. 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Biotex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12008: 12009: 12016: 12021: 12023: 12024: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2025

2016: 12017: 22018: 22019: 12022: 12025: 1
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biotex, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biotex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument4decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • OCXEndoscopic Irrigation/Suction System2decisions
  • LQZDevice, Jaw Repositioning1decision
  • HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)1decision

Whose devices does it build on?

Its devices cite 17 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060304Photex Diode Laser Series, Models 980, 810 and 940Biotex, Inc. · 20065cite it
  • K053087Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemBiotex, Inc. · 20064cite it
  • K161704Phasor DrillBiotex, Inc. · 20163cite it
  • K071328Visualase Thermal Therapy SystemBiotex, Inc. · 20072cite it
  • K063505Visualase Envision Software SystemBiotex, Inc. · 20061cites it
  • K222695troCarWash™ SystemBiotex, Inc. · 20231cites it

What has FDA decided for it lately?

  • K233442troCarWash™ SystemBiotex, Inc. · 2024
  • K222695troCarWash™ SystemBiotex, Inc. · 2023
  • K203712The SlideBiotex, Inc. · 2021
  • K161704Phasor DrillBiotex, Inc. · 20161 recall
  • K092197PHOTEX30 Diode Laser Series: 980, 810, 940Biotex, Inc. · 2009
  • K081656Visualase Thermal Therapy SystemBiotex, Inc. · 20081 recall
  • K071328Visualase Thermal Therapy SystemBiotex, Inc. · 20071 recall
  • K063505Visualase Envision Software SystemBiotex, Inc. · 2006

All 10 as Biotex, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K161704Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35Mar 21, 2025Class II
  • K181859Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP…Oct 14, 2022Class II
  • K071328Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559…Jul 8, 2019Class II
  • K081656Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2…Jun 1, 2018Class II
  • K053087Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559…Mar 23, 2018Class II
  • K053087VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled…Jul 27, 2017Class II