FDA.reportPublic FDA data

VIOPTIX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039653643003965364VIOPTIX, INC.1N2026-01-0139655 Eureka Dr Newark CA US 94560

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B426OXY2DUR10Intra.Ox Smart Sensor - OXY2-DUR-1510-226-5860info@vioptix.com
B426OXY2SPD10T.Ox SP Sensor - OXY-2-SPD-1510-226-5860info@vioptix.com
B426OXY2SPI10T.Ox SS Sensor - OXY2-SPI-1510-226-5860info@vioptix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
607801894931293K250519Lap.Ox™ Laparoscopic Tissue OximeterMUD2025-06-26
607801059340832K233488Intra.Ox™ 2.0 Handheld Tissue OximeterMUD2024-02-28
607801891883864K221010Intra.Ox 2.0 Handheld Tissue OximeterMUD2022-05-03
607802067331844K191676Intra.Ox 2.0 Handheld Tissue OximeterMUD2019-09-16
607801765087897K163472Intra.Ox Handheld Tissue OximeterMUD2017-11-16
607801431889236K141234ODISSEY TISSUE OXIMETERMUD2014-07-01
607801729801682K133983INTRA. OX HANDHELD TISSUE OXIMETERMUD2014-09-12
607801651158707K042657VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2MUD2005-01-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUD82025-06-26

PMN#

GUDID#