Biotex, Inc.

FDA Regulatory Profile

Biotex, Inc. appears in FDA public data with 0 recalls, 10 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 21, 2024.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K233442troCarWash™ SystemMay 21, 2024
K222695troCarWash™ SystemFeb 17, 2023
K203712The SlideJul 20, 2021
K161704Phasor DrillDec 1, 2016
K092197PHOTEX30 DIODE LASER SERIES: 980, 810, 940Oct 6, 2009
K081656VISUALASE THERMAL THERAPY SYSTEMSep 10, 2008
K071328VISUALASE THERMAL THERAPY SYSTEMAug 31, 2007
K063505VISUALASE ENVISION SOFTWARE SYSTEMDec 12, 2006
K060304PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940Mar 21, 2006
K053087VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEMMar 1, 2006