Biotex, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233442troCarWash™ SystemMay 21, 2024
K222695troCarWash™ SystemFebruary 17, 2023
K203712The SlideJuly 20, 2021
K161704Phasor DrillDecember 1, 2016
K092197PHOTEX30 DIODE LASER SERIES: 980, 810, 940October 6, 2009
K081656VISUALASE THERMAL THERAPY SYSTEMSeptember 10, 2008
K071328VISUALASE THERMAL THERAPY SYSTEMAugust 31, 2007
K063505VISUALASE ENVISION SOFTWARE SYSTEMDecember 12, 2006
K060304PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940March 21, 2006
K053087VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEMMarch 1, 2006