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FDA 510(k)

Lap.Ox™ Laparoscopic Tissue Oximeter

K-Number: K250519 · 2025-06-26

ApplicantViOptix, Inc.
Decision Date2025-06-26
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lap.Ox™ Laparoscopic Tissue Oximeter is a medical device manufactured by ViOptix, Inc.. It received FDA 510(k) clearance on 2025-06-26 under approval number K250519. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lap.Ox™ Laparoscopic Tissue Oximeter?

Lap.Ox™ Laparoscopic Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by ViOptix, Inc.. The 510(k) number is K250519.

When was Lap.Ox™ Laparoscopic Tissue Oximeter approved by the FDA?

Lap.Ox™ Laparoscopic Tissue Oximeter received FDA 510(k) clearance on 2025-06-26, under approval number K250519.

What company makes Lap.Ox™ Laparoscopic Tissue Oximeter?

Lap.Ox™ Laparoscopic Tissue Oximeter is manufactured by ViOptix, Inc..

What is the FDA product code for Lap.Ox™ Laparoscopic Tissue Oximeter?

The FDA product code for Lap.Ox™ Laparoscopic Tissue Oximeter is MUD.

Related Clinical Trials

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Related Devices (Code: MUD)

K153426Ox-Imager CSModulated Imaging, Inc. K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc. K162117NIRO-200NX DPHamamatsu Photonics K.K. K160526Masimo O3 Regional Oximeter SystemMasimo Corporation K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. K162603Masimo O3 Regional Oximeter SystemMasimo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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