Vioptix, Inc.
United StatesFDA applicant, unverified FDA FEI 3003965364
Vioptix, Inc. is a medical device manufacturer, with 14 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 13 Nov 2026.
- Devices
- 14
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 9
- FDA GUDID 5
- Device classes
- FDA Class II 14
- Identifiers
- FDA FEI 3003965364
- DUNS 127211923
At a glance
Market reach
- United States
- FDA FEI
What Vioptix, Inc. makes
Vioptix, Inc. manufactures single-use tissue saturation oximeter sensors and handheld tissue oximeters designed for intraoperative and laparoscopic monitoring. Their products include disposable sensors, optical quality control targets, and handheld devices for measuring tissue oxygenation, such as the Intra.Ox 2.0 and Lap.Ox Laparoscopic Tissue Oximeter.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries.
Catalogue
Search and filter all 14 devicesCompany details
- FDA FEI number
- 3003965364
- DUNS number
- 127211923
- Address
- 39655 Eureka Dr, Newark, CA, 94560
- info@vioptix.com
- Phone
- 510-226-5860
Frequently asked questions
How many devices does VIOPTIX, INC. have in the registry?
The registry currently lists 14 devices for VIOPTIX, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list VIOPTIX, INC.'s devices?
Among its 14 most recently registered devices, VIOPTIX, INC. has devices listed in FDA 510(k) (9 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do VIOPTIX, INC.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for VIOPTIX, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from VIOPTIX, INC. in the registry?
The most recently registered devices listed for VIOPTIX, INC. include T.Ox SP Sensor OXY-2-SPD-1, Intra.Ox Smart Sensor OXY2-DUR-1, Intra.Ox Disposable Sheath OXY2-STH-1 and Intra.Ox Optical QC Target OXY2-QCT-1.