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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 the device name listed in this FDA 510(k) record. The listed applicant is ViOptix, Inc.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) 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. The listed applicant is ViOptix, Inc.. The 510(k) number is K250519.

When did Lap.Ox™ Laparoscopic Tissue Oximeter receive FDA 510(k) clearance?

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

Who is the listed applicant for Lap.Ox™ Laparoscopic Tissue Oximeter?

The FDA 510(k) record lists ViOptix, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing ViOptix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233488Intra.Ox™ 2.0 Handheld Tissue OximeterK221010Intra.Ox 2.0 Handheld Tissue OximeterK191676Intra.Ox 2.0 Handheld Tissue OximeterK163472Intra.Ox Handheld Tissue Oximeter

Related Devices (Code: MUD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254129Spectrum-2Neko Health ABK243324Masimo O3 Regional OximeterMasimo CorporationK240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards LifesciencesK241393ODI-TechOdi Medical ASK240601SnapshotNIR model KD205Kent Imaging, Inc.K232385OxiplexTS200Iss Medical, Inc.

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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