Vioptix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250519Lap.Ox™ Laparoscopic Tissue OximeterJune 26, 2025
K233488Intra.Ox™ 2.0 Handheld Tissue OximeterFebruary 28, 2024
K221010Intra.Ox 2.0 Handheld Tissue OximeterMay 3, 2022
K191676Intra.Ox 2.0 Handheld Tissue OximeterSeptember 16, 2019
K163472Intra.Ox Handheld Tissue OximeterNovember 16, 2017
K133983INTRA. OX HANDHELD TISSUE OXIMETERSeptember 12, 2014
K141234ODISSEY TISSUE OXIMETERJuly 1, 2014
K090679VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEMApril 17, 2009
K042657VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2January 10, 2005