Medical Device Manufacturer · US , Irvine , CA

Vioptix, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2005

Recent clearances: Lap.Ox™ Laparoscopic Tissue Oximeter, Intra.Ox™ 2.0 Handheld Tissue Oximeter, Intra.Ox 2.0 Handheld Tissue Oximeter

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Vioptix, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Nov 16, 2017

Intra.Ox Handheld Tissue Oximeter

Cardiovascular · 339d

Cleared Sep 12, 2014

INTRA. OX HANDHELD TISSUE OXIMETER

Cardiovascular · 259d

Cleared Jul 01, 2014

ODISSEY TISSUE OXIMETER

Cardiovascular · 49d

Cleared Jan 10, 2005

VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2

Cardiovascular · 104d