# Biotex, Inc.

- Location (FDA's records): Houston, TX
- FDA decisions: 10 (2006–2024): 10 510(k) clearances
- Product codes: GEX (4), LLZ (2), OCX (2), LQZ (1), HBE (1)
- Predicates its devices cite: 17 (6 its own); citations of its devices by later devices: 18 (6 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgical Laser Technologies, Inc.: 3 (https://510kreport.com/company/surgical-laser-technologies)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Indigo Medical, Inc.: 1 (https://510kreport.com/company/indigo-medical)
- Cipher Surgical Limited: 1 (https://510kreport.com/company/cipher-surgical)
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd: 1 (https://510kreport.com/company/changzhou-xin-neng-yuan-medical-stapler)
- Kmi Kolster Methods, Inc.: 1 (https://510kreport.com/company/kmi-kolster-methods)
- Somnomed, Inc.: 1 (https://510kreport.com/company/somnomed)
- Microaire Surgical Instruments, LLC: 1 (https://510kreport.com/company/microaire-surgical-instruments)

## Firms that cite its devices most
- Phasor Health, LLC: 2 (https://510kreport.com/company/phasor-health)
- Clinical Laserthermia Systems, AB: 2 (https://510kreport.com/company/clinical-laserthermia-systems)
- Monteris Medical,: 1 (https://510kreport.com/company/monteris-medical)
- Litecure, LLC: 1 (https://510kreport.com/company/litecure)
- B&W Tek, Inc.: 1 (https://510kreport.com/company/b-w-tek)
- Elesta S.P.A: 1 (https://510kreport.com/company/elesta)
- Hubly, Inc.: 1 (https://510kreport.com/company/hubly)
- Nomir Medical Technologies, Inc.: 1 (https://510kreport.com/company/nomir-medical-technologies)

## Its most-cited devices
- K060304: Photex Diode Laser Series, Models 980, 810 and 940 (2006), cited by 5
- K053087: Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System (2006), cited by 4
- K161704: Phasor Drill (2016), cited by 3
- K071328: Visualase Thermal Therapy System (2007), cited by 2
- K063505: Visualase Envision Software System (2006), cited by 1
- K222695: troCarWash™ System (2023), cited by 1

## Recent decisions
- K233442: troCarWash™ System (May 21, 2024)
- K222695: troCarWash™ System (Feb 17, 2023)
- K203712: The Slide (Jul 20, 2021)
- K161704: Phasor Drill (Dec 1, 2016)
- K092197: PHOTEX30 Diode Laser Series: 980, 810, 940 (Oct 6, 2009)
- K081656: Visualase Thermal Therapy System (Sep 10, 2008)
- K071328: Visualase Thermal Therapy System (Aug 31, 2007)
- K063505: Visualase Envision Software System (Dec 12, 2006)

Source page: https://510kreport.com/company/biotex